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A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Primary Purpose

Gastroparesis, Diabetes Mellitus

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Relamorelin
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Type 1 or Type 2 diabetes mellitus
  • Meet the per protocol criteria of diabetic gastroparesis
  • Compliance with diary
  • Compliance with the per protocol study treatment dosing instructions

Exclusion Criteria:

  • Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube
  • Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating disorder at the time of Screening (Visit 1)
  • Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity
  • History of gastrointestinal disorders that may be similar to gastroparesis
  • Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus

Sites / Locations

  • University of Alabama at Birmingham
  • Digestive Health Specialist of the South East
  • Avant Research Associates
  • Synexus Clinical Research US, Inc.
  • Central Arizona Medical Associates
  • Phoenix Clinical LLC
  • Del Sol Research Management, LLC
  • Preferred Research Partners, Inc.
  • Arkansas Gastorenterology
  • Hope Clinical Research
  • Kindred Medical Institute for Clinical Trials, LLC
  • Aurora Care Clinic, LLC
  • Citrus Valley Gastroenterology Clinic
  • VVCRD Research
  • University of California San Diego
  • Om Research LLC
  • Clinical Applications Laboratories, Inc.
  • Medical Associates Research Group, Inc
  • Synexus Clinical Research, US, Santa Rosa
  • Upland Clinical Research
  • Synexus Clinical Research US, Inc.
  • University of Colorado, Denver
  • Peak Gastroenterology Associates
  • Denver Esophageal and Stomach Center
  • Connecticut Clinical Research Foundation
  • Medical Research Center of Connecticut, LLC
  • TrialSpark, Inc.
  • Innovative Research of West FL, Inc.
  • West Central Gastroenterology
  • American Research Institute, Inc
  • Top Medical Research
  • Nature Coast Clinical Research
  • Cfagi Llc
  • Savin Medical Group LLC
  • APF Research LLC
  • AMPM Research Clinic
  • Advanced Medical Research Institute
  • Florida Research Center, Inc.
  • Sensible Healthcare
  • Gulf Region Clinical Research Institute
  • University of South Florida
  • West Central Gastroenterology
  • Summit Clinical Research, LLC
  • Infinite Clinical Trials
  • Southwest Gastroenterology
  • MediSphere Medical Research Center, LLC
  • Synexus Clinical Research US, Inc.
  • Indiana University Health University Hospital
  • University of Iowa Hospitals and Clinics
  • University of Kansas Medical Center
  • Cotton-O'Neil Clinical Research Center - Digestive Health
  • University of Louisville
  • Delta Research Partners
  • Cronola LLC
  • New Orleans Research Institute - Metropolitan Gastroenterology Associates
  • Gastro Center of Maryland
  • Frederick Gastroenterology Associates, PA an Elligo Health Research Site
  • Boston VA Healthcare System
  • Vida Clinical Studies
  • National Clinical, LLC
  • Henry Ford Health System
  • Gastroenterology Associates of Western Michigan
  • MNGI Digestive Health
  • Synexus Clinical Research US, Inc.
  • Montana Medical Research
  • Synexus Clinical Research
  • Excel Clinical Research
  • Clinical Research of South Nevada
  • Advanced Biomedical Research of America
  • Digestive Disease Specialists
  • Palm Research Center
  • Garden State Endocrinology
  • Synexus Clinical Research US, Inc.
  • AGA Clinical Research Associates LLC
  • CHEAR Center, LLC
  • Long Island Gastrointestinal Research Group LLP
  • United Health Services Hospitals, Inc.
  • Asheville Gastroenterology Associates
  • University of North Carolina at Chapel Hill
  • Carolinas Healthcare-Charlotte
  • Carolina Digestive Health Associates
  • Cumberland Research Associates, LLC
  • Triad Clinical Trials
  • PMG Research Salisbury
  • The Center for Clinical Research
  • Dayton Gastroenterology,Inc.
  • Endocrinology Research Associates, Inc.
  • Hometown Urgent Care and Research
  • Premier Clinical Research d.b.a. STAT Research
  • Family Practice Center of Wadsworth, Inc.
  • Digestive Disease Specialists Inc
  • Memorial Clinical Research
  • Northwest Gastroenterology Clinic, LLC
  • Family Medical Associates, Research Department
  • Preferred Primary Care Physicians, Inc.
  • Montgomery Medical, Inc.
  • Synexus Clinical Research US, Inc.
  • Carolina Medical Research
  • Gastroenterology Associates, PA
  • Synexus Clinical Research
  • Quality Medical Research
  • Avant Research Associates,LLC
  • Synexus Clinical Research US, Inc.
  • Amir Ali Hassan, MD, PA
  • Clinical Trials of Texas, Inc.
  • Sagact Pllc
  • Synexus Clinical Research US, Inc.
  • Synexus Clinical Research US, Inc.
  • Advanced Research Institute, Inc.
  • Advanced Clinical Research
  • Verity Research Inc.
  • Cardinal Internal Medicine
  • West Virginia University
  • Nepean Hospital
  • Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
  • The Alfred Hospital
  • Royal Melbourne Hospital
  • MHAT Yuliya Vrevska Byala
  • UMHAT - Kaspela- EOOD
  • Medical Center Asklepion - Humane Medicine Research EOOD
  • Alexandrovska University Hospital
  • CHU Nantes
  • Hopital Charles Nicolle
  • Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
  • King George Hospital
  • Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology
  • Victoria Hospital
  • Life Care Hospital & Research Centre
  • Diacon Hospital and research Center - Diabetology
  • Rajalakshmi Hospital
  • Vinaya Hospital & Research Centre
  • Bhatia Hospital
  • B. J. Government Medical College and Sassoon General Hospitals
  • Universal Hospital
  • Noble Hospital Pvt. Ltd
  • S R Kalla (SRK) Memorial Gastro & General Hospital
  • SMS Hospital
  • Diabetic Thyroid and Endocrine Centre
  • Marudhar Hospital
  • Eternal Hospital - Diabetology
  • M.V. Hospital for Diabetes & Diabetes Research Centre
  • Kovai Diabetes Speciality Centre
  • M V Hospital & Research Centre
  • Arthur Asirvatham Hospital
  • Sir Ganga Ram Hospital
  • Soroka University Medical Center
  • Bnai Zion Medical Center
  • E. Wolfson Medical Center
  • Digestive Diseases Institute
  • Gastroenterology Institute
  • Endocrinology & Diabetes Center
  • Gastroenterology Institute
  • Chonbuk National University Hospital
  • Sanggye Paik Hospital, Inje University College of Medicine
  • Asan Medical Center
  • Hospital Sultanah Bahiyah
  • University Malaya Medical Centre
  • Universiti Sains Malaysia
  • Hospital Taiping
  • Manila Doctors Hospital
  • San Juan De Dios Educational Foundation, Inc.
  • Cardinal Santos Medical Center
  • Ospital ng Makati
  • Perpetual Succor Hospital
  • West Visayas State University Medical Center
  • St. Luke's Medical Center
  • Synexus Polska Sp.z o.o.
  • CenterMed Krakow Ltd
  • Centrum Medyczne Pratia S.A. Warsaw, Poland
  • Endoskopia Sp. Z O.O.
  • Synexus Polska Sp. z o.o.Oddzial w Poznaniu
  • Wojewodzki Szpital Specjalistyczny w Olsztynie
  • NZOZ Vita Diabetica - Malgorzata Buraczyk
  • Centrum Medyczne Lukamed
  • Synexus Polska sp.z.o.o oddzial Czestochowa
  • Specjalistyczny Gabinet Neurologiczny Marta Banach
  • Synexus Polska Sp. z o.o. Oddzial w Lodzi
  • Sanitas Centrum Medyczne
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • DRS Wroclaw
  • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
  • National University Hospital
  • Changi General Hospital
  • Singapore General Hospital
  • Hospital Universitario Principe de Asturias
  • Hospital Universitario De Salamanca
  • Hospital Universitario Virgen del Rocío
  • Phramongkutklao Hospital
  • Faculty of Medicine, Siriraj Hospital, Mahidol University
  • Maharaj Nakorn Chiang Mai Hospital
  • Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
  • Limited Liability Company "Medical Center "Salutem"
  • Municipal Institution City Hospital No. 7
  • Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C
  • Regional Public Organization Chernivtsi Regional Endocrinology Center
  • State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
  • Ivano-Frankivsk National Medical University
  • Ivano-Frankivsk Central City Clinical Hospital
  • Municipal nonprofit entity of Kharkiv municipal council
  • L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
  • Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
  • Communal Institution Kherson City Clinical Hospital
  • Kyiv municipal clinical endocrinological center
  • AS Medbud Clinic
  • AS PVNZ
  • Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
  • Kyiv Railway hospital on the railway transport #2 of the branch "health
  • Medical Center Universal Clinic Oberig
  • Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
  • Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
  • Poltava Regional Clinical Hospital
  • Ternopil University Hospital
  • Private Small-Scale Enterprise Medical Centre Pulse
  • Vinnytsia Regional Clinical highly specialized Endocrinology Centre
  • Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
  • 6th City Clinical Hospital, c. Zaporizhzhia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Relamorelin 10 μg

Arm Description

Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.

Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.

Outcomes

Primary Outcome Measures

Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the Run-in Period.
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.

Secondary Outcome Measures

Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea.
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary.
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary.
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst).
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Number of Participants With Clinically Meaningful Trends for Vital Signs
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound.
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.

Full Information

First Posted
September 14, 2017
Last Updated
July 8, 2021
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03285308
Brief Title
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
Official Title
A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
The Relamorelin program is being terminated solely based on a business decision.
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
July 8, 2020 (Actual)
Study Completion Date
July 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.
Arm Title
Relamorelin 10 μg
Arm Type
Experimental
Arm Description
Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injected subcutaneously twice daily.
Intervention Type
Drug
Intervention Name(s)
Relamorelin
Intervention Description
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Description
Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the Run-in Period.
Time Frame
Baseline (Day-14 to Day-1) to Week 12
Title
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period.
Time Frame
Week 6 to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description
A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the 12-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea.
Time Frame
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Title
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description
An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the 12-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary.
Time Frame
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Title
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description
A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the 12-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary.
Time Frame
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Title
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period
Description
A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the 12-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst).
Time Frame
Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Title
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
Description
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Time Frame
Up to approximately 16 weeks
Title
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Description
Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time Frame
Up to 12 weeks
Title
Number of Participants With Clinically Meaningful Trends for Vital Signs
Description
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant.
Time Frame
Up to 12 weeks
Title
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Description
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Time Frame
Up to 12 weeks
Title
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Description
HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound.
Time Frame
Baseline (Day 1) up to 12 weeks
Title
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
Description
A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.
Time Frame
Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Type 1 or Type 2 diabetes mellitus Meet the per protocol criteria of diabetic gastroparesis Compliance with diary Compliance with the per protocol study treatment dosing instructions Exclusion Criteria: Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating disorder at the time of Screening (Visit 1) Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity History of gastrointestinal disorders that may be similar to gastroparesis Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wieslaw (Wes) Bochenek, MD, PhD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35295
Country
United States
Facility Name
Digestive Health Specialist of the South East
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Avant Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Fountain Hills
State/Province
Arizona
ZIP/Postal Code
85268
Country
United States
Facility Name
Central Arizona Medical Associates
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Phoenix Clinical LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Preferred Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Arkansas Gastorenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Kindred Medical Institute for Clinical Trials, LLC
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Aurora Care Clinic, LLC
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Citrus Valley Gastroenterology Clinic
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
VVCRD Research
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Clinical Applications Laboratories, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Medical Associates Research Group, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Synexus Clinical Research, US, Santa Rosa
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Upland Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
University of Colorado, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Denver Esophageal and Stomach Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Connecticut Clinical Research Foundation
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Medical Research Center of Connecticut, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
TrialSpark, Inc.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Innovative Research of West FL, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
West Central Gastroenterology
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
American Research Institute, Inc
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Top Medical Research
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Cfagi Llc
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Savin Medical Group LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
APF Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
AMPM Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Advanced Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Florida Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Sensible Healthcare
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Gulf Region Clinical Research Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
West Central Gastroenterology
City
Tampa
State/Province
Florida
ZIP/Postal Code
33626
Country
United States
Facility Name
Summit Clinical Research, LLC
City
Carnesville
State/Province
Georgia
ZIP/Postal Code
30521
Country
United States
Facility Name
Infinite Clinical Trials
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Indiana University Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center - Digestive Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Delta Research Partners
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Cronola LLC
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
New Orleans Research Institute - Metropolitan Gastroenterology Associates
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Gastro Center of Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Frederick Gastroenterology Associates, PA an Elligo Health Research Site
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
Facility Name
Boston VA Healthcare System
City
West Roxbury
State/Province
Massachusetts
ZIP/Postal Code
02132
Country
United States
Facility Name
Vida Clinical Studies
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
National Clinical, LLC
City
Hamtramck
State/Province
Michigan
ZIP/Postal Code
48212
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
MNGI Digestive Health
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55423
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Synexus Clinical Research
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Clinical Research of South Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Digestive Disease Specialists
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Palm Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Garden State Endocrinology
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08723
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Bridgeton
State/Province
New Jersey
ZIP/Postal Code
08302
Country
United States
Facility Name
AGA Clinical Research Associates LLC
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
CHEAR Center, LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Facility Name
Long Island Gastrointestinal Research Group LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
United Health Services Hospitals, Inc.
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Asheville Gastroenterology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7080
Country
United States
Facility Name
Carolinas Healthcare-Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Triad Clinical Trials
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
PMG Research Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Dayton Gastroenterology,Inc.
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Endocrinology Research Associates, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Premier Clinical Research d.b.a. STAT Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Family Practice Center of Wadsworth, Inc.
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Digestive Disease Specialists Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Memorial Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Northwest Gastroenterology Clinic, LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Family Medical Associates, Research Department
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Montgomery Medical, Inc.
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Carolina Medical Research
City
Clinton
State/Province
South Carolina
ZIP/Postal Code
29325
Country
United States
Facility Name
Gastroenterology Associates, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Synexus Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Quality Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Avant Research Associates,LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Amir Ali Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sagact Pllc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Verity Research Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Cardinal Internal Medicine
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22192
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
MHAT Yuliya Vrevska Byala
City
Byala
State/Province
Ruse
ZIP/Postal Code
7100
Country
Bulgaria
Facility Name
UMHAT - Kaspela- EOOD
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Medical Center Asklepion - Humane Medicine Research EOOD
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Facility Name
Alexandrovska University Hospital
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
CHU Nantes
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Kumudini Devi Diabetes Research Center; Ramdevrao Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500072
Country
India
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380007
Country
India
Facility Name
Victoria Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Life Care Hospital & Research Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560092
Country
India
Facility Name
Diacon Hospital and research Center - Diabetology
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
359-360
Country
India
Facility Name
Rajalakshmi Hospital
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560097
Country
India
Facility Name
Vinaya Hospital & Research Centre
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Facility Name
Bhatia Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400007
Country
India
Facility Name
B. J. Government Medical College and Sassoon General Hospitals
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Universal Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Noble Hospital Pvt. Ltd
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411013
Country
India
Facility Name
S R Kalla (SRK) Memorial Gastro & General Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302001
Country
India
Facility Name
SMS Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Facility Name
Diabetic Thyroid and Endocrine Centre
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302006
Country
India
Facility Name
Marudhar Hospital
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302012
Country
India
Facility Name
Eternal Hospital - Diabetology
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
M.V. Hospital for Diabetes & Diabetes Research Centre
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600013
Country
India
Facility Name
Kovai Diabetes Speciality Centre
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641009
Country
India
Facility Name
M V Hospital & Research Centre
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Arthur Asirvatham Hospital
City
Madurai
ZIP/Postal Code
625020
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Soroka University Medical Center
City
Beer Sheba
ZIP/Postal Code
85025
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
E. Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Digestive Diseases Institute
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Gastroenterology Institute
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Endocrinology & Diabetes Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Gastroenterology Institute
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-Do
ZIP/Postal Code
561-712
Country
Korea, Republic of
Facility Name
Sanggye Paik Hospital, Inje University College of Medicine
City
Seoul
State/Province
Nowon-gu
ZIP/Postal Code
01757
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
5460
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Universiti Sains Malaysia
City
Kubang Kerian
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Hospital Taiping
City
Taiping
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Manila Doctors Hospital
City
Ermita
State/Province
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
San Juan De Dios Educational Foundation, Inc.
City
Pasay
State/Province
Metro Manila
ZIP/Postal Code
1300
Country
Philippines
Facility Name
Cardinal Santos Medical Center
City
San Juan City
State/Province
Metro Manila
ZIP/Postal Code
1502
Country
Philippines
Facility Name
Ospital ng Makati
City
Makati City
State/Province
NCR
ZIP/Postal Code
1218
Country
Philippines
Facility Name
Perpetual Succor Hospital
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
West Visayas State University Medical Center
City
IloIlo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
St. Luke's Medical Center
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Synexus Polska Sp.z o.o.
City
Pomorskie
State/Province
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
CenterMed Krakow Ltd
City
Krakow
State/Province
Malopolska
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Centrum Medyczne Pratia S.A. Warsaw, Poland
City
Warsaw
State/Province
Mazowian
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Endoskopia Sp. Z O.O.
City
Sopot
State/Province
Pomorskie
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Synexus Polska Sp. z o.o.Oddzial w Poznaniu
City
Poznan
State/Province
Poznañ
ZIP/Postal Code
60-702
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny w Olsztynie
City
Olsztyn
State/Province
Warmia-Mazury
ZIP/Postal Code
10-561
Country
Poland
Facility Name
NZOZ Vita Diabetica - Malgorzata Buraczyk
City
Bialystok
ZIP/Postal Code
15-798
Country
Poland
Facility Name
Centrum Medyczne Lukamed
City
Chojnice
ZIP/Postal Code
89-600
Country
Poland
Facility Name
Synexus Polska sp.z.o.o oddzial Czestochowa
City
Czestochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
Specjalistyczny Gabinet Neurologiczny Marta Banach
City
Kraków
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Lodzi
City
Lodz
ZIP/Postal Code
90-127
Country
Poland
Facility Name
Sanitas Centrum Medyczne
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
Country
Poland
Facility Name
DRS Wroclaw
City
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
City
Wroclaw
ZIP/Postal Code
51-162
Country
Poland
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
S169856
Country
Singapore
Facility Name
Hospital Universitario Principe de Asturias
City
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Hospital Universitario De Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Communal Institution "Odesa Regional Clinical Hospital", Out-patient department
City
Odesa
State/Province
Odesa Region
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Limited Liability Company "Medical Center "Salutem"
City
Vinnitsa
State/Province
Vinnyts'ka Oblast'
ZIP/Postal Code
21050
Country
Ukraine
Facility Name
Municipal Institution City Hospital No. 7
City
Zaporizhzhia
State/Province
Zaporizhzhia Region
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Regional Public Organization Chernivtsi Regional Endocrinology Center
City
Chernivtsi
ZIP/Postal Code
58022
Country
Ukraine
Facility Name
State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Ivano-Frankivsk National Medical University
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Ivano-Frankivsk Central City Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Municipal nonprofit entity of Kharkiv municipal council
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Communal Institution Kherson City Clinical Hospital
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Kyiv municipal clinical endocrinological center
City
Kyiv
ZIP/Postal Code
01034
Country
Ukraine
Facility Name
AS Medbud Clinic
City
Kyiv
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
AS PVNZ
City
Kyiv
ZIP/Postal Code
2002
Country
Ukraine
Facility Name
Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv
City
Kyiv
ZIP/Postal Code
2002
Country
Ukraine
Facility Name
Kyiv Railway hospital on the railway transport #2 of the branch "health
City
Kyiv
ZIP/Postal Code
3049
Country
Ukraine
Facility Name
Medical Center Universal Clinic Oberig
City
Kyiv
ZIP/Postal Code
3680
Country
Ukraine
Facility Name
Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit
City
Kyiv
ZIP/Postal Code
4050
Country
Ukraine
Facility Name
Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University
City
Odesa
ZIP/Postal Code
65010
Country
Ukraine
Facility Name
Poltava Regional Clinical Hospital
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Ternopil University Hospital
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Private Small-Scale Enterprise Medical Centre Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical highly specialized Endocrinology Centre
City
Vinnytsia
ZIP/Postal Code
21010
Country
Ukraine
Facility Name
Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", c. Vinnytsia
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
6th City Clinical Hospital, c. Zaporizhzhia
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

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A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

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