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Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly (MPOWERED)

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Octreotide capsules
Sponsored by
Chiasma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Octreotide Capsules, Acromegaly, somatostatin receptor ligands (SRLs), Mpowered, OOC-ACM-302

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of acromegaly
  • Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months
  • Biochemical control (IGF -1 < 1.3 x ULN and GH < 2.5ng/mL)

Exclusion Criteria:

  • Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks.
  • Pituitary radiotherapy within 5 years
  • Pituitary surgery within six months
  • Patients who previously participated in CH-ACM-01 study
  • Any clinically significant uncontrolled concomitant disease
  • Symptomatic cholelithiasis
  • Previous treatment with:
  • Pegvisomant, within 12 weeks
  • Dopamine agonists, within 6 weeks
  • Pasireotide, within 12 weeks

Sites / Locations

  • University of Alabama at Birmingham
  • Keck Medical Center of University of Southern California
  • Cedars-Sinai Medical Center
  • Stanford University School of Medicine
  • University of Colorado Denver
  • Emory University
  • Northwestern University
  • John H. Stroger, Jr. Hospital of Cook County
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Washington University School of Medicine
  • Rutgers - Robert Wood Johnson Medical School
  • Columbia University Medical Center
  • The Ohio State University Wexner Medical Center
  • Thomas Jefferson University
  • Allegheny Endocrinology Associates
  • Baylor College of Medicine
  • Houston Methodist Research Institute
  • Universitätsklinik für Innere Medizin Klinische Abteilung für Endokrinologie und Diabetologie
  • Medizinische Universität Wien
  • Hospices Civils de Lyon
  • Hôpital Bicêtre APHP
  • Praxis für Endokrinologie und Diabetologie Dr M Droste
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • University of Pecs
  • Szegedi Tudományegyetem, I. Belgyógyászati Klinika
  • Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
  • Università di Pisa Dipartimento di Medicina Clinica e Sperimentale
  • Fondazione Policlinico Universitario A. Gemelli Università Cattolica del S.Cuore S.C. Endocrinologia e Malattie del Metabolismo
  • Hospital of LUHS Kauno Klinikos
  • Vaidotas Urbanavicius Individuali Imonė
  • Katedra i Klinika Endokrynologii i Chorob Wewnetrznych Gdanski Uniwersytet Medyczny
  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
  • "C.I. Parhon" National Institute of Endocrinology I Clinical Endocrinology Department - Endemic goitier and its complications
  • Antrium Multidisciplinary Medical Clinic
  • Interregional Clinical Diagnostic Center
  • Regional State Budgetary Healthcare Institution Regional State Hospital
  • Sechenov Moscow First State Medical University
  • "Atlas" Medical Center
  • Vladimirsky Moscow Regional Research Clinical Institute
  • Novosibirsk State Regional Clinical Hospital
  • Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation
  • "Centre Diabetes" LLC
  • Clinical Centre of Serbia, Clinic for Endocrinology Diabetes and Metabolic Diseases
  • Hospital Universitario de la Ribera
  • Hospital Universitari Germans Trias i Pujol
  • Hospital General Universitario Gregorio Maranon
  • Complejo Hospitalario Universitario de Santiago de Compostela
  • Campus Del Hospital Universitario Virgen del Rocio
  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
  • Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary
  • Royal Victoria Infirmary
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Run-in phase

RCT phase - Oral

RCT phase - Injectables

Combination phase (sub-study)

Arm Description

Oral octreotide capsules

Oral octreotide capsules

Injectable somatostatin analogs (octreotide or lanreotide)

Octreotide capsules plus cabergoline

Outcomes

Primary Outcome Measures

Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase
Proportion of patients who are biochemically controlled throughout the RCT phase. A patient was considered biochemically controlled if IGF-1 Time Weighted Average (TWA) during the RCT phase is <1.3 ULN

Secondary Outcome Measures

Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase
Proportion of patients with clinical and biochemical control at the end of the RCT phase. Patients were considered biochemically and clinically controlled if they met both of the following criteria: Their IGF-1 TWA during the RCT phase was <1.3 times ULN Their AIS score at week 62/EOT was maintained or reduced compared to week 26 (start of RCT phase)
Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase
Proportion of patients who maintain or reduce the overall number of active acromegaly symptoms at the end of the RCT phase (week 62/ EOT) , compared to week 26 (start of the RCT phase
Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase
Proportion of patients who maintain or improve their overall Acromegaly index of severity (AIS) score at the end of the RCT phase (improvement defined as a reduction of at least one point in the AIS score), compared to week 26 (start of the RCT phase)
Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase
Proportion of patients of those completing the RCT phase (at a time octreotide capsules were not commercially available at the specific country), who entered the Study Extension phase, overall and by treatment group
Change in IGF-1 Levels in the RCT Phase
Change in IGF-1 levels from the start of the randomized phase to the end of RCT phase. Complete Responder (CR) is defined as IGF-1 ≤ 1 x ULN; Partial Responder (PR) is defined as 1 x ULN < IGF-1 < 1.3 x ULN, and Non-Responder (NR): IGF-1 ≥ 1.3 x ULN
Change in GH Levels in the RCT Phase
Change in GH levels from the start of the randomized phase through the end of RCT phase.

Full Information

First Posted
January 28, 2016
Last Updated
March 24, 2022
Sponsor
Chiasma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02685709
Brief Title
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Acronym
MPOWERED
Official Title
A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
August 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiasma, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs).
Detailed Description
This was phase 3, randomized, open-label, active controlled, multicenter study to evaluate the maintenance of response, safety and patient reported outcomes (PROs) in acromegaly patients treated with octreotide capsules and in patients treated with standard of care parenteral somatostatin receptor ligands (SRLs), who previously tolerated and demonstrated biochemical control on both treatments. The core study consisted of three phases: a Screening phase, Run-in phase and a Randomized Controlled Treatment (RCT) phase. Eligible patients who were biochemically controlled on parenteral SRLs were switched to octreotide capsules for a 26-week period Run-in phase. During this phase the effective dose for each patient was determined through dose titration. Patients whose acromegaly has been controlled biochemically on octreotide capsules at the end of the Run-in phase entered a 36-week open-label RCT phase, where they randomized to continue on octreotide capsules or switch back to their injectable SRL treatment (as received prior to Screening). Following the completion of the core study (Screening, Run-in and RCT phases), eligible patients were offered to enter the Study Extension phase and receive octreotide capsules until product marketing or study termination. A Sub-study, performed in selected non-European sites, allowed patients with inadequate biochemical control on octreotide capsules during the Run-in phase to enter a Combination phase and receive co-administration of octreotide capsules with cabergoline tablets for a total of 36 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Octreotide Capsules, Acromegaly, somatostatin receptor ligands (SRLs), Mpowered, OOC-ACM-302

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Run-in phase
Arm Type
Experimental
Arm Description
Oral octreotide capsules
Arm Title
RCT phase - Oral
Arm Type
Experimental
Arm Description
Oral octreotide capsules
Arm Title
RCT phase - Injectables
Arm Type
Active Comparator
Arm Description
Injectable somatostatin analogs (octreotide or lanreotide)
Arm Title
Combination phase (sub-study)
Arm Type
Experimental
Arm Description
Octreotide capsules plus cabergoline
Intervention Type
Drug
Intervention Name(s)
Octreotide capsules
Other Intervention Name(s)
Injection SRLs
Primary Outcome Measure Information:
Title
Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase
Description
Proportion of patients who are biochemically controlled throughout the RCT phase. A patient was considered biochemically controlled if IGF-1 Time Weighted Average (TWA) during the RCT phase is <1.3 ULN
Time Frame
62 weeks
Secondary Outcome Measure Information:
Title
Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase
Description
Proportion of patients with clinical and biochemical control at the end of the RCT phase. Patients were considered biochemically and clinically controlled if they met both of the following criteria: Their IGF-1 TWA during the RCT phase was <1.3 times ULN Their AIS score at week 62/EOT was maintained or reduced compared to week 26 (start of RCT phase)
Time Frame
Week 62/ End of treatment; EOT
Title
Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase
Description
Proportion of patients who maintain or reduce the overall number of active acromegaly symptoms at the end of the RCT phase (week 62/ EOT) , compared to week 26 (start of the RCT phase
Time Frame
62 weeks
Title
Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase
Description
Proportion of patients who maintain or improve their overall Acromegaly index of severity (AIS) score at the end of the RCT phase (improvement defined as a reduction of at least one point in the AIS score), compared to week 26 (start of the RCT phase)
Time Frame
62 weeks
Title
Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase
Description
Proportion of patients of those completing the RCT phase (at a time octreotide capsules were not commercially available at the specific country), who entered the Study Extension phase, overall and by treatment group
Time Frame
62 weeks
Title
Change in IGF-1 Levels in the RCT Phase
Description
Change in IGF-1 levels from the start of the randomized phase to the end of RCT phase. Complete Responder (CR) is defined as IGF-1 ≤ 1 x ULN; Partial Responder (PR) is defined as 1 x ULN < IGF-1 < 1.3 x ULN, and Non-Responder (NR): IGF-1 ≥ 1.3 x ULN
Time Frame
Change from Week 26 to week 62
Title
Change in GH Levels in the RCT Phase
Description
Change in GH levels from the start of the randomized phase through the end of RCT phase.
Time Frame
Change from Week 26 to week 62
Other Pre-specified Outcome Measures:
Title
Proportion of Patients Reporting Injection Site Reactions in the Acro-TSQ During the RCT Phase
Description
Proportion of patients reporting injection site reactions (ISRs). Acromegaly treatment satisfaction questionnaire (ACRO-TSQ) is a validated PRO tool assessing overall convenience and satisfaction with treatment and patient perception of symptomatic control and adverse drug. It includes 6 scales: Symptom Interference, (4 items); Treatment Convenience, (6 items); Injection Site Interference (2 items); GI Interference (3 items); Treatment Satisfaction, (3 items); and Emotional Reaction (3 items). Each scale score can range from 0 to 100, with 0 representing the lowest (highest burden/lower satisfaction) and 100 representing the best possible score (lowest burden/highest satisfaction) for each of the 6 scales. Positive ACRO-TSQ change scores indicate improvement while negative change scores indicate worsening.
Time Frame
62 weeks
Title
Proportion of Patients Reporting Interference With Daily Activities in Acro-TSQ During the RCT Phase
Description
Proportion of patients reporting interference with daily activities in the Acromegaly Treatment Satisfaction Questionnaire (Acro-TSQ) during the RCT phase. Acro-TSQ is a validated PRO tool assessing overall convenience and satisfaction with treatment and patient perception of symptomatic control and adverse drug. It includes 6 scales: Symptom Interference, (4 items); Treatment Convenience, (6 items); Injection Site Interference (2 items); GI Interference (3 items); Treatment Satisfaction, (3 items); and Emotional Reaction (3 items). Each scale score can range from 0 to 100, with 0 representing the lowest (highest burden/lower satisfaction) and 100 representing the best possible score (lowest burden/highest satisfaction) for each of the 6 scales. Positive Acro-TSQ change scores indicate improvement while negative change scores indicate worsening.
Time Frame
62 weeks
Title
Proportion of Patients on Octreotide Capsules Who Are Biochemically Controlled at the End of the RCT Phase- Landmark Analysis
Description
Proportion of patients on octreotide capsules who are biochemically controlled at the end of the RCT phase defined as IGF-1< 1.3 x ULN based on average of weeks 58 and 62
Time Frame
Average of weeks 58 and 62
Title
Proportion of Week 26 Responders on Octreotide Capsules Who Are Biochemically Controlled at the End of the RCT Phase- Landmark Sensitivity Analysis
Description
Proportion of patients on Octreotide Capsules Who Are Biochemically Controlled at the End of the RCT Phase- Landmark sensitivity analysis- Week 26 responders
Time Frame
62 weeks
Title
Proportion of Patients Biochemically Controlled at the End of Run-in
Description
Proportion of patients biochemically controlled at the end of the Run-in phase, defined as average IGF-1 levels during weeks 24 and 26 < 1.3xULN
Time Frame
26 weeks
Title
Proportion of Patients With a Reduction in the Overall Number of Active Acromegaly Symptoms at the End of the Run-in Phase
Description
Proportion of patients with a reduction in the overall number of active acromegaly symptoms at the end of the Run-in phase compared to Baseline
Time Frame
26 weeks
Title
Proportion of Patients With Improved Acromegaly Index of Severity (AIS) Score at the End of the Run-in Phase
Description
Proportion of patients with improved AIS score at the end of the Run-in phase compared to Baseline Acromegaly index of severity (AIS) at the end of Run-in phase compared to Baseline. The Acromegaly Index of Severity (AIS) symptom score is calculated based on the presence and severity of 5 acromegaly signs/symptoms: headache, swelling of extremities, joint pain, sweating, and fatigue. Each symptom was graded from no symptoms (score 0), to mild symptoms (1), moderate (2), or severe symptoms (3).
Time Frame
26 weeks
Title
EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Index Scores During the Run-in Phase
Description
Change from baselines in EQ-5D-5L Index scores in randomized participants during the Run-in phase. EQ-5D-5L (five severity levels EQ-5D) is a standardized instrument completed by the patient for use as a measure of health outcome applicable to a wide range of health conditions. It comprises 5 dimensions of health: mobility, ability to self care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. Based on qualitative and quantitative studies conducted by the EuroQol Group, there are 5 levels under each domain: 'no problems' (assigned a value of 1), 'slight problems' (assigned a value of 2), 'moderate problems' (assigned a value of 3), 'severe problems' (assigned a value of 4), and 'unable to/extreme problems' (assigned a value of 5). An EQ-5D Index score is calculated based on the responses to these 5 dimensions of health. Weights for use in the index calculation are not universally available. Higher values represent better health states.
Time Frame
26 weeks
Title
Change From Baseline to End of RCT Phase in WPAI
Description
Work Productivity and Activity Impairment Questionnaire- RCT phase. WPAI:SHP is a standardized and validated PRO questionnaire to measure health outcomes in clinical trial settings. It measures time missed from work, impairment of work and regular activities due to overall health and symptoms, relative to measures of general health perceptions, role (physical), role (emotional), pain, symptom severity, and global measures of work and interference with regular activity. The WPAI yields 4 types of scores: (1) absenteeism (work time missed); (2) presenteeism (impairment at work/reduced on-the-job effectiveness); (3) work productivity loss (overall work impairment/absenteeism plus presenteeism); and (4) activity impairment. Each of the 4 WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity (i.e., worse outcomes).
Time Frame
26 weeks
Title
Change From Baseline to End of Run-in Phase in WPAI
Description
Work Productivity and Activity Impairment Questionnaire- Run-in phase. WPAI:SHP is a standardized and validated PRO questionnaire to measure health outcomes in clinical trial settings. It measures time missed from work, impairment of work and regular activities due to overall health and symptoms, relative to measures of general health perceptions, role (physical), role (emotional), pain, symptom severity, and global measures of work and interference with regular activity. The WPAI yields 4 types of scores: (1) absenteeism (work time missed); (2) presenteeism (impairment at work/reduced on-the-job effectiveness); (3) work productivity loss (overall work impairment/absenteeism plus presenteeism); and (4) activity impairment. Each of the 4 WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity (i.e., worse outcomes).
Time Frame
62 weeks
Title
Change in Acromegaly Treatment Satisfaction Questionnaire (ACRO-TSQ) Scores From Baseline to End of Run-in in Randomized Patients.
Description
Change in Acromegaly treatment satisfaction questionnaire (ACRO-TSQ) PRO questionnaire from baseline to end of Run-in phase in randomized patients. Acro-TSQ is a validated PRO tool assessing overall convenience and satisfaction with treatment and patient perception of symptomatic control and adverse drug. It includes 6 scales: Symptom Interference, (4 items); Treatment Convenience, (6 items); Injection Site Interference (2 items); GI Interference (3 items); Treatment Satisfaction, (3 items); and Emotional Reaction (3 items). Each scale score can range from 0 to 100, with 0 representing the lowest (highest burden/lower satisfaction) and 100 representing the best possible score (lowest burden/highest satisfaction) for each of the 6 scales. Positive Acro-TSQ change scores indicate improvement while negative change scores indicate worsening.
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of acromegaly Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months Biochemical control (IGF -1 < 1.3 x ULN and GH < 2.5ng/mL) Exclusion Criteria: Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks. Pituitary radiotherapy within 5 years Pituitary surgery within six months Patients who previously participated in CH-ACM-01 study Any clinically significant uncontrolled concomitant disease Symptomatic cholelithiasis Previous treatment with: Pegvisomant, within 12 weeks Dopamine agonists, within 6 weeks Pasireotide, within 12 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Fleseriu, M.D., FACE
Organizational Affiliation
Northwest Pituitary Center, Oregon Health & Science University , Portland, OR, USA
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Keck Medical Center of University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John H. Stroger, Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny Endocrinology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Universitätsklinik für Innere Medizin Klinische Abteilung für Endokrinologie und Diabetologie
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hôpital Bicêtre APHP
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Praxis für Endokrinologie und Diabetologie Dr M Droste
City
Oldenburg
ZIP/Postal Code
26122
Country
Germany
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
H-1062
Country
Hungary
Facility Name
University of Pecs
City
Pecs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
Szegedi Tudományegyetem, I. Belgyógyászati Klinika
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
City
Monserrato
ZIP/Postal Code
09042
Country
Italy
Facility Name
Università di Pisa Dipartimento di Medicina Clinica e Sperimentale
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli Università Cattolica del S.Cuore S.C. Endocrinologia e Malattie del Metabolismo
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Hospital of LUHS Kauno Klinikos
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Vaidotas Urbanavicius Individuali Imonė
City
Vilnius
ZIP/Postal Code
LT-10207
Country
Lithuania
Facility Name
Katedra i Klinika Endokrynologii i Chorob Wewnetrznych Gdanski Uniwersytet Medyczny
City
Gdańsk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
"C.I. Parhon" National Institute of Endocrinology I Clinical Endocrinology Department - Endemic goitier and its complications
City
Bucharest
ZIP/Postal Code
011863
Country
Romania
Facility Name
Antrium Multidisciplinary Medical Clinic
City
Barnaul
ZIP/Postal Code
656043
Country
Russian Federation
Facility Name
Interregional Clinical Diagnostic Center
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Regional State Budgetary Healthcare Institution Regional State Hospital
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Sechenov Moscow First State Medical University
City
Moscow
ZIP/Postal Code
119881
Country
Russian Federation
Facility Name
"Atlas" Medical Center
City
Moscow
ZIP/Postal Code
121170
Country
Russian Federation
Facility Name
Vladimirsky Moscow Regional Research Clinical Institute
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Novosibirsk State Regional Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
"Centre Diabetes" LLC
City
Samara
ZIP/Postal Code
443041
Country
Russian Federation
Facility Name
Clinical Centre of Serbia, Clinic for Endocrinology Diabetes and Metabolic Diseases
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Hospital Universitario de la Ribera
City
Alzira
ZIP/Postal Code
46600
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Campus Del Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
46013
Country
Spain
Facility Name
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25664604
Citation
Melmed S, Popovic V, Bidlingmaier M, Mercado M, van der Lely AJ, Biermasz N, Bolanowski M, Coculescu M, Schopohl J, Racz K, Glaser B, Goth M, Greenman Y, Trainer P, Mezosi E, Shimon I, Giustina A, Korbonits M, Bronstein MD, Kleinberg D, Teichman S, Gliko-Kabir I, Mamluk R, Haviv A, Strasburger C. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1699-708. doi: 10.1210/jc.2014-4113. Epub 2015 Feb 9. Erratum In: J Clin Endocrinol Metab. 2016 Oct;101(10 ):3863. J Clin Endocrinol Metab. 2020 Dec 1;105(12):
Results Reference
background
PubMed Identifier
26610414
Citation
Melmed S. New therapeutic agents for acromegaly. Nat Rev Endocrinol. 2016 Feb;12(2):90-8. doi: 10.1038/nrendo.2015.196. Epub 2015 Nov 27.
Results Reference
background
PubMed Identifier
34953531
Citation
Fleseriu M, Dreval A, Bondar I, Vagapova G, Macut D, Pokramovich YG, Molitch ME, Leonova N, Raverot G, Grineva E, Poteshkin YE, Gilgun-Sherki Y, Ludlam WH, Patou G, Haviv A, Gordon MB, Biermasz NR, Melmed S, Strasburger CJ. Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2022 Feb;10(2):102-111. doi: 10.1016/S2213-8587(21)00296-5. Epub 2021 Dec 22. Erratum In: Lancet Diabetes Endocrinol. 2022 Mar;10(3):e3.
Results Reference
derived
Links:
URL
http://www.chiasmapharma.com
Description
Click here for more information about Chiasma

Learn more about this trial

Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

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