Back to resultsA Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
Primary Purpose
Diabetic Gastroparesis
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CIN-102 Dose 1
CIN-102 Dose 2
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Gastroparesis focused on measuring Gastroparesis, Diabetic gastroparesis, Gastrointestinal disease, Delayed gastric emptying, Digestive system diseases, Nausea, Vomiting, Stomach, Dopamine receptor antagonist
Eligibility Criteria
Key Inclusion Criteria: Is a male or female ≥18 years of age; Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria; Has a current diagnosis of diabetic gastroparesis defined by the following: Gastrointestinal symptoms felt to be consistent with gastroparesis within 6 months prior to Screening; AND Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry. Body mass index (BMI) between 18 and 45 kg/m2, inclusive; Glycosylated hemoglobin (HbA1c) level <10% at Screening; Willing to washout from ongoing treatment for gastroparesis. Key Exclusion Criteria: Has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesis and/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, or other neurologic disorder); History or evidence of clinically significant arrhythmia; History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery; Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression; Pyloric injection of botulinum toxin within 6 months of Screening; Positive test for drugs of abuse; Has a known allergy to eggs or spirulina; Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
Sites / Locations
- Digestive Health Specialists of the SoutheastRecruiting
- G & L Research, LLCRecruiting
- Clinical Research Associates, LLCRecruiting
- Phoenix Medical Research Institute, LLCRecruiting
- Adobe Clinical Research, LLCRecruiting
- Del Sol Research Management, LLCRecruiting
- Preferred Research Partners, Inc.Recruiting
- Applied Research Center of ArkansasRecruiting
- Arkansas Gastroenterology - North Little RockRecruiting
- Hope Clinical Research LLCRecruiting
- Kindred Medical Institute for Clinical Trials, LLCRecruiting
- New Hope Research DevelopmentRecruiting
- Aurora Care ClinicRecruiting
- Paragon Rx ClinicalRecruiting
- Valley View Wellness and Medical Center - VVCRDRecruiting
- Torrance Clinical Research Institute Inc.Recruiting
- Angel City ResearchRecruiting
- Precision Research Institute, LLCRecruiting
- Millennium Clinical TrialsRecruiting
- Innovative Research of West FloridaRecruiting
- USA and International Research Inc.Recruiting
- Advanced Medical Research GroupRecruiting
- Nature Coast Clinical ResearchRecruiting
- ClinCloud LLCRecruiting
- A+ Research IncRecruiting
- International Research Associates LLC - BretonRecruiting
- Advanced Research Institute IncRecruiting
- Gastroenterology of Greater OrlandoRecruiting
- Tandem Clinical Research - VieraRecruiting
- Summit Clinical Research, LLCRecruiting
- Medisphere Medical Research CenterRecruiting
- University of Kansas Medical Center (KUMC)Recruiting
- Kansas Medical Clinic, P.A.Recruiting
- Alliance for Multispecialty Research - Wichita WestRecruiting
- University of LouisvilleRecruiting
- Tandem Clinical Research GI - HoumaRecruiting
- Tandem Clinical ResearchRecruiting
- Tandem Clinical Research GI - MetairieRecruiting
- Delta Research PartnersRecruiting
- Clinical Research Institute of Michigan, LLCRecruiting
- Aa Mrc, LlcRecruiting
- Clinical Research Institute of Michigan, LLC - TroyRecruiting
- Gastroenterology Associates of Western MichiganRecruiting
- Kansas City Research InstituteRecruiting
- Washington University School of MedicineRecruiting
- Montana Medical Research, Inc.Recruiting
- American Institute of Medical ResearchRecruiting
- Digestive Disease SpecialistsRecruiting
- Allied Health Clinical Research Organization, LLC (AHCRO) - EnglewoodRecruiting
- Allied Health Clinical Research Organization, LLC (AHCRO) - FreeholdRecruiting
- Allied Health Clinical Research Organization, LLC (AHCRO) - JacksonRecruiting
- Velocity Clinical Research - SyracuseRecruiting
- Long Island Gastrointestinal Research GroupRecruiting
- Smart Medical ResearchRecruiting
- Tandem Clinical Research GI- New YorkRecruiting
- A1 Clinical NetworkRecruiting
- Atrium Health - Center for Digestive HealthRecruiting
- Coastal Research Institute, LLCRecruiting
- Triad Clinical Trials LLCRecruiting
- Carolina's GI ResearchRecruiting
- OnSite Clinical Solutions, LLCRecruiting
- Northshore Gastroenterology Research, LLCRecruiting
- Options Health ResearchRecruiting
- Velocity Clinical ResearchRecruiting
- Susquehanna Research Group, LLCRecruiting
- WR ClinSearchRecruiting
- Galen Medical Group - Downtown Gastroenterology LocationRecruiting
- North Hills Medical Research Inc. (North Hills Familiy Medicine)Recruiting
- Zenos Clinical ResearchRecruiting
- Texas Tech University Health Sciences CenterRecruiting
- Amir A Hassan, MD, PARecruiting
- Care and Cure ClinicRecruiting
- Pioneer Research Solutions Inc.Recruiting
- Biopharma Informatic, LLCRecruiting
- A1 Clinical NetworkRecruiting
- HP Clinical Research (Val R. Hansen)Recruiting
- Velocity Clinical Research - Salt Lake CityRecruiting
- Manassas Clinical Research CenterRecruiting
- Wisconsin Center for Advanced ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CIN-102 Dose 1
CIN-102 Dose 2
Placebo
Arm Description
Dose 1 twice daily for 12 weeks
Dose 2 twice daily for 12 weeks
Placebo twice daily for 12 weeks
Outcomes
Primary Outcome Measures
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline based on the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale scores and the Vomiting subscale scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe)
Secondary Outcome Measures
Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement.
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment emergent Serious Adverse Events (SAEs)
Incidence of TEAEs leading to premature discontinuation of study drug
Incidence of treatment-emergent marked laboratory abnormalities.
Estimates based on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores using Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) as an anchor Sub-Scale
Justification for obtaining estimates using both PGIS and PGIC is provide accumulated evidence to help interpret a clinically meaningful within-patient score change as outcome anchors.
Percentage of subjects with a history of a lack of response or who could not tolerate metoclopramide therapy or other prokinetics, who demonstrate a >30% reduction on a composite score
Composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores
Percentage of subjects who are identified as responders, defined as an average ≥0.5 reduction from baseline on their ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores
Percentage of subjects achieving a ≥30% reduction from baseline on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores
Percentage of subjects achieving a ≥30% reduction from baseline on the average ANMS GCSI-DD Vomiting Sub-Scale Score
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
Based on the average ANMS GCSI-DD Nausea Sub-Scale Score
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
Based on the average ANMS GCSI-DD Vomiting Sub-Scale Score
Percentage of subjects achieving a ≥30% reduction from baseline on the average ANMS GCSI-DD Nausea Sub-Scale Score
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms
Based on the average ANMS GCSI-DD Total Score
Percentage of subjects achieving a ≥30% reduction on the average ANMS GCSI-DD Total Score
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms based on the ANMS GCSI-DD Early Satiety Sub-Scale Score
Average ANMS GCSI-DD Early Satiety Sub-Scale Score
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms
Based on the average ANMS GCSI-DD Postprandial Fullness Sub-Scale Score
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms
Based on the average ANMS GCSI-DD Upper Abdominal Pain Sub-Scale Score
Percentage of symptom-free days in the ANMS GCSI-DD Total Score, a composite of the Nausea and Vomiting Scores, Nausea Score, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, and Upper Abdominal Pain Score with each dose of CIN-102
Symptomatic days defined as >mild (ANMS GCSI-DD scores >2)
All endpoints that are evaluated over the last 2 weeks of the 12-week Treatment period will also be evaluated over the last 6 weeks of the 12-week Treatment period.
Change in the PGIS with each dose of CIN-102
Change in the PGIC with each dose of CIN-102
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05832151
Brief Title
A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subjects With Diabetic Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
October 23, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CinDome Pharma, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this clinical trial is to evaluate if the study drug CIN-102 (deudomperidone) can help reduce the symptoms associated with diabetic gastroparesis in adult patients.
The main questions it aims to answer are:
To evaluate the efficacy of CIN-102 on symptoms of gastroparesis when given to patients with diabetic gastroparesis compared to a placebo
To evaluate the safety and tolerability of CIN-102 when given to patients with diabetic gastroparesis compared to a placebo
Participants will go through the following schedule:
Screening period (1-2 visits)
Lead-in period (1 visit)
Will complete a Gastric Emptying Breath Test (GEBT)
Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued study participation
12-week treatment period (5 visits)
Study drug taken twice daily by mouth
Will complete daily diaries and other PROs as described in protocol
1 week follow-up (1 visit)
Researchers will compare the effects of the following treatments:
Drug- CIN-102 Dose 1
Drug- CIN-102 Dose 2
Drug- Placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
Keywords
Gastroparesis, Diabetic gastroparesis, Gastrointestinal disease, Delayed gastric emptying, Digestive system diseases, Nausea, Vomiting, Stomach, Dopamine receptor antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CIN-102 Dose 1
Arm Type
Experimental
Arm Description
Dose 1 twice daily for 12 weeks
Arm Title
CIN-102 Dose 2
Arm Type
Experimental
Arm Description
Dose 2 twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CIN-102 Dose 1
Intervention Description
2 capsules twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CIN-102 Dose 2
Intervention Description
2 capsules twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 capsules twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline based on the composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores
Description
The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) Nausea Subscale scores and the Vomiting subscale scores will be averaged into a single value that ranges 0-4 (0 for no symptom and 4 for very severe)
Time Frame
Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Secondary Outcome Measure Information:
Title
Incidence of clinically significant changes, in the Investigator's opinion, in laboratory parameters, physical examination findings, 12-lead ECG parameters, weight measurement.
Time Frame
Over the 12-week Treatment Period
Title
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame
Over the 12-week Treatment Period
Title
Incidence of treatment emergent Serious Adverse Events (SAEs)
Time Frame
Over the 12-week Treatment Period
Title
Incidence of TEAEs leading to premature discontinuation of study drug
Time Frame
Over the 12-week Treatment Period
Title
Incidence of treatment-emergent marked laboratory abnormalities.
Time Frame
Over the 12-week Treatment Period
Title
Estimates based on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores using Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) as an anchor Sub-Scale
Description
Justification for obtaining estimates using both PGIS and PGIC is provide accumulated evidence to help interpret a clinically meaningful within-patient score change as outcome anchors.
Time Frame
Over the last 2 weeks for the 12-week Treatment Period
Title
Percentage of subjects with a history of a lack of response or who could not tolerate metoclopramide therapy or other prokinetics, who demonstrate a >30% reduction on a composite score
Description
Composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores
Time Frame
Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Title
Percentage of subjects who are identified as responders, defined as an average ≥0.5 reduction from baseline on their ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores
Time Frame
Over the last 2 weeks of the 12-week Treatment Period
Title
Percentage of subjects achieving a ≥30% reduction from baseline on a composite of the average ANMS GCSI-DD Nausea Sub-Scale and Vomiting Sub-Scale Scores
Time Frame
Over the last 2 weeks of the 12-week Treatment Period
Title
Percentage of subjects achieving a ≥30% reduction from baseline on the average ANMS GCSI-DD Vomiting Sub-Scale Score
Time Frame
Over the last 2 weeks of the 12-week Treatment Period
Title
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
Description
Based on the average ANMS GCSI-DD Nausea Sub-Scale Score
Time Frame
Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Title
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms as compared to baseline
Description
Based on the average ANMS GCSI-DD Vomiting Sub-Scale Score
Time Frame
Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Title
Percentage of subjects achieving a ≥30% reduction from baseline on the average ANMS GCSI-DD Nausea Sub-Scale Score
Time Frame
Over the last 2 weeks of the 12-week Treatment Period
Title
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms
Description
Based on the average ANMS GCSI-DD Total Score
Time Frame
Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Title
Percentage of subjects achieving a ≥30% reduction on the average ANMS GCSI-DD Total Score
Time Frame
Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Title
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms based on the ANMS GCSI-DD Early Satiety Sub-Scale Score
Description
Average ANMS GCSI-DD Early Satiety Sub-Scale Score
Time Frame
Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Title
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms
Description
Based on the average ANMS GCSI-DD Postprandial Fullness Sub-Scale Score
Time Frame
Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Title
Effect of CIN-102 to significantly decrease the severity of gastroparesis-related symptoms
Description
Based on the average ANMS GCSI-DD Upper Abdominal Pain Sub-Scale Score
Time Frame
Over the last 2 weeks of the 12-week Treatment Period as compared to baseline
Title
Percentage of symptom-free days in the ANMS GCSI-DD Total Score, a composite of the Nausea and Vomiting Scores, Nausea Score, Vomiting Score, Early Satiety Score, Postprandial Fullness Score, and Upper Abdominal Pain Score with each dose of CIN-102
Description
Symptomatic days defined as >mild (ANMS GCSI-DD scores >2)
Time Frame
Over the last 2 weeks of the 12-week Treatment Period
Title
All endpoints that are evaluated over the last 2 weeks of the 12-week Treatment period will also be evaluated over the last 6 weeks of the 12-week Treatment period.
Time Frame
Over the last 6 weeks of the 12-week Treatment Period
Title
Change in the PGIS with each dose of CIN-102
Time Frame
From baseline to Week 12
Title
Change in the PGIC with each dose of CIN-102
Time Frame
From baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Is a male or female ≥18 years of age;
Has a diagnosis of Type 1 or Type 2 diabetes, according to the American Diabetes Association criteria;
Has a current diagnosis of diabetic gastroparesis defined by the following:
Gastrointestinal symptoms felt to be consistent with gastroparesis within 6 months prior to Screening; AND
Documented delayed gastric emptying as determined by gastric emptying breath test (GEBT), scintigraphy, or manometry.
Body mass index (BMI) between 18 and 45 kg/m2, inclusive;
Glycosylated hemoglobin (HbA1c) level <10% at Screening;
Willing to washout from ongoing treatment for gastroparesis.
Key Exclusion Criteria:
Has known cause of gastroparesis other than diabetes (eg, idiopathic gastroparesis and/or gastroparesis attributed to surgery, viral illness, cancer, scleroderma, or other neurologic disorder);
History or evidence of clinically significant arrhythmia;
History of pyloroplasty, pyloromyotomy, or gastric peroral endoscopic myotomy, fundoplication, gastrectomy, vagotomy, or bariatric surgery;
Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression;
Pyloric injection of botulinum toxin within 6 months of Screening;
Positive test for drugs of abuse;
Has a known allergy to eggs or spirulina;
Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachael Farley
Phone
+1.513.579.9911
Ext
11961
Email
R.Farley@Medpace.com
Facility Information:
Facility Name
Digestive Health Specialists of the Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Barnes
Phone
334-305-2406
Email
dbarnes@dothangi.com
Facility Name
G & L Research, LLC
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Fuller
Phone
251-943-2980
Email
glresearch5@gmail.com
Facility Name
Clinical Research Associates, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peg Rochine
Phone
256-536-6600
Email
prochine@cra-al.biz
Facility Name
Phoenix Medical Research Institute, LLC
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Chasse
Phone
623-815-9800
Email
nchasse@phxresearch.com
Facility Name
Adobe Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
520-318-1236
Email
lori@adobegastro.com
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvia Parra
Phone
520-827-4263
Email
eparra@delsolresearch.com
Facility Name
Preferred Research Partners, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Watson
Phone
501-553-9987
Ext
106
Email
jwatson@preferredresearchpartners.com
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rhonda Rowton
Phone
501-954-7822
Email
rhonda@arcarkansas.com
Facility Name
Arkansas Gastroenterology - North Little Rock
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Voss
Phone
501-945-9300
Email
kenneth@arkgi.net
Facility Name
Hope Clinical Research LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Manzano
Phone
818-257-3140
Email
jmanzano@hopeclinical.com
Facility Name
Kindred Medical Institute for Clinical Trials, LLC
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaushik Gupta
Phone
951-220-4029
Email
drkg@aol.com
Facility Name
New Hope Research Development
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Costa
Phone
562-506-8879
Email
ebcosca@nhrdevelopment.com
Facility Name
Aurora Care Clinic
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
949-764-9314
Email
matthew@aurorafdrc.com
Facility Name
Paragon Rx Clinical
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlynn Musil
Phone
714-655-5382
Email
caitlynn.musil@prxclinical.com
Facility Name
Valley View Wellness and Medical Center - VVCRD
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene Morales
Phone
855-229-1665
Email
morales@vvcrd.com
Facility Name
Torrance Clinical Research Institute Inc.
City
Lomita
State/Province
California
ZIP/Postal Code
09717
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Arsate
Phone
424-203-8984
Email
miriamarsate@hotmail.com
Facility Name
Angel City Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maira Jackson
Phone
213-365-0793
Ext
114
Email
maira@angelcityresearch.com
Facility Name
Precision Research Institute, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josefina Summers
Phone
619-501-0371
Ext
309
Email
josie@prisandiego.com
Facility Name
Millennium Clinical Trials
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Nielsen
Phone
805-496-3322
Email
michelle@millenniumct.com
Facility Name
Innovative Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
727-584-6368
Email
Traceyo@innovativeresearchfl.com
Facility Name
USA and International Research Inc.
City
Doral
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-548-0709
Email
felix.perez@usairesearch.com
Facility Name
Advanced Medical Research Group
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
954-589-2766
Email
MaiteMenendez@advancedmedicalresearchgroup.com
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Cenatiempo
Phone
352-341-2100
Email
Lcenatiempo@encoredocs.com
Facility Name
ClinCloud LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-636-4031
Email
MTaylor@mclincloud.com
Facility Name
A+ Research Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-229-4053
Email
niurka@aplusresearch.co
Facility Name
International Research Associates LLC - Breton
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-670-8830
Ext
x104
Email
dalvarez@intrallc.com
Facility Name
Advanced Research Institute Inc
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
727-835-3261
Ext
x105
Email
Lynnette.mitchell@ariclinical.com
Facility Name
Gastroenterology of Greater Orlando
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parteek Sharma
Phone
386-668-2221
Email
psharma@gastro-md.com
Facility Name
Tandem Clinical Research - Viera
City
Viera
State/Province
Florida
ZIP/Postal Code
32940
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-680-0534
Email
mrobinson@myclincloud.com
Facility Name
Summit Clinical Research, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Wilson
Phone
706-400-4262
Email
bwilson@summitclinicalstudies.com
Facility Name
Medisphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leticia Cauvel
Phone
812-471-4110
Email
lcauvel@medisphereresearch.com
Facility Name
University of Kansas Medical Center (KUMC)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Torneden
Phone
913-574-0533
Email
jtorneden2@kumc.edu
Facility Name
Kansas Medical Clinic, P.A.
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susie Roeder
Phone
785-295-0938
Email
sroeder@kmcpa.com
Facility Name
Alliance for Multispecialty Research - Wichita West
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Pham
Phone
316-838-7700
Email
Kelly.Pham@amrllc.com
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Perdue
Email
amy.perdue@louisville.edu
Facility Name
Tandem Clinical Research GI - Houma
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70363
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
504-934-8424
Email
elinvog@tandemclinicalresearch.com
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Valence
Phone
504-934-8424
Email
bvalence@tandemclinicalresearch.com
Facility Name
Tandem Clinical Research GI - Metairie
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
504-934-8092
Email
jodom@tandemclinicalresearch.com
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa McCullars
Phone
318-807-0819
Email
mmccullars@gastromds.com
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
586-598-3329
Email
jhooks@researchmi.com
Facility Name
Aa Mrc, Llc
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
810-237-1125
Email
fshah@aamrc.net
Facility Name
Clinical Research Institute of Michigan, LLC - Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawn Gedvilas
Phone
586-598-3329
Email
dgedvilas@researchmi.com
Facility Name
Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
616-328-5344
Email
akrautwurst@gastro-assoc-wm.com
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taleah Brown
Phone
816-759-5274
Email
tbrown@kcri.health
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Bruns
Phone
314-747-5366
Email
brunsj@wustl.edu
Facility Name
Montana Medical Research, Inc.
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marria Hegel
Phone
406-549-1124
Email
mhegel@montanamedicalresearch.com
Facility Name
American Institute of Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
702-898-2088
Email
aimresearchmd@gmail.com
Facility Name
Digestive Disease Specialists
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Davis
Phone
702-290-2951
Email
rdavis@lvresearch.com
Facility Name
Allied Health Clinical Research Organization, LLC (AHCRO) - Englewood
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Kim
Phone
201-992-8272
Email
kkim@allieddigestivehealth.com
Facility Name
Allied Health Clinical Research Organization, LLC (AHCRO) - Freehold
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Aversa
Phone
732-724-2500
Email
daversa@allieddigestivehealth.com
Facility Name
Allied Health Clinical Research Organization, LLC (AHCRO) - Jackson
City
Jackson
State/Province
New Jersey
ZIP/Postal Code
08527
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaina Patel
Phone
732-724-2500
Email
shpatel@allieddigestivehealth.com
Facility Name
Velocity Clinical Research - Syracuse
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Hall
Phone
315-760-5905
Email
chall@velocityclinical.com
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
516-482-5976
Email
christineraiser@ligiresearch.com
Facility Name
Smart Medical Research
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11372
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahboob Ali
Phone
347-754-8380
Email
mali@smartmedicalresearch.com
Facility Name
Tandem Clinical Research GI- New York
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Perez-Avalin
Phone
646-386-7574
Email
gperez-avilan@tandemclinicalresearch.com
Facility Name
A1 Clinical Network
City
Richmond Hill
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maaryj Ahmad
Phone
832-375-4730
Email
maaryjiftikhar@gmail.com
Facility Name
Atrium Health - Center for Digestive Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Crawford
Phone
704-667-5324
Email
jamie.crawford@atriumhealth.org
Facility Name
Coastal Research Institute, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Shoffner
Phone
910-500-3146
Email
BSHOFFNER@COASTALRESEARCHNC.COM
Facility Name
Triad Clinical Trials LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Riggs
Phone
336-235-0991
Email
sriggs@triad.twcbc.com; sriggs@triadclinicaltrials.com
Facility Name
Carolina's GI Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marsha Peery
Phone
919-781-2514
Email
mpeery@wakeresearch.com
Facility Name
OnSite Clinical Solutions, LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothy Moran
Phone
800-785-3150
Email
dmoran@onsiteclinical.com
Facility Name
Northshore Gastroenterology Research, LLC
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Peachy
Phone
440-808-1212
Email
jpeachey@northshoregastro.org
Facility Name
Options Health Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
918-513-3490
Ext
x104
Email
debbie.langley@okgastro.com
Facility Name
Velocity Clinical Research
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danuel Hamlin
Phone
541-858-1018
Email
dhamlin@velocityclinical.com
Facility Name
Susquehanna Research Group, LLC
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Balay
Phone
717-914-7770
Email
jbalay@gicare.com
Facility Name
WR ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vickie Leathers
Phone
423-698-4584
Email
vleathers@clinsearch-us.com
Facility Name
Galen Medical Group - Downtown Gastroenterology Location
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Herman
Phone
423-308-0280
Ext
2040
Email
therman@galenmedical.com
Facility Name
North Hills Medical Research Inc. (North Hills Familiy Medicine)
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ted Melliza
Phone
817-595-3399
Email
t.melliza@nhmr-inc.com
Facility Name
Zenos Clinical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miasimone Glasco
Phone
496-949-4900
Email
mglasco@zenosclinicalresearch.com
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Vasquez
Phone
915-215-4388
Email
denise.vasquez@ttuhsc.edu
Facility Name
Amir A Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deysi Fernandez
Email
Deysi@biopharmainfo.net
Facility Name
Care and Cure Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
832-885-7723
Email
ahussain@springclinicalresearch.com
Facility Name
Pioneer Research Solutions Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khurram Shah
Phone
713-333-9323
Email
khurram@pioneerresearchsolutions.com
Facility Name
Biopharma Informatic, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Lagos
Phone
281-944-3610
Email
adriana@biopharmainfo.net
Facility Name
A1 Clinical Network
City
Spring
State/Province
Texas
ZIP/Postal Code
77386
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Schumyla Sarfraz
Phone
832-374-5273
Email
schumyla@a1clinical.com
Facility Name
HP Clinical Research (Val R. Hansen)
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melody Pope
Phone
801-292-1422
Email
mpope425@live.com
Facility Name
Velocity Clinical Research - Salt Lake City
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Holtman
Email
HHoltman@velocityclinical.com
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
703-330-1112
Email
jyotsna@andrawis.com
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Dunneboil
Phone
414-908-6630
Email
kellyd@wigia.com
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.gastroparesistrial.com/
Description
Study website
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adults With Diabetic Gastroparesis
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