Primary outcomeCount of participants· 62 weeks
Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase
| Group | Value (Participants) |
|---|---|
| RCT Phase - Oral | 50 |
| RCT Phase - Injectables | 37 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataComparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Short name MPOWERED
NCTNCT02685709 (opens ClinicalTrials.gov in a new tab)Other idOOC-ACM-302Other id2015-002854-11Other id2015
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 146 participants (actual)
- Sponsor
- Chiasma, Inc. · Industry
- Design
- Randomized · Open label (no masking)
- Countries
13 countries
United States, Austria, France, Germany, Hungary, Italy, Lithuania, Poland, Romania, Russia, Serbia, Spain, United Kingdom
- Start
- Feb 2016
- Primary completion
- Oct 2020
- Completion
- Aug 2021
- First posted
- 19 Feb 2016 (estimated)
- Last update posted
- 22 Apr 2022
- Conditions
- Acromegaly
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2016201720182019202020212022
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- Octreotide capsulesDrug
Arms4
Experimental
Run-in phase
Oral octreotide capsules
Experimental
RCT phase - Oral
Oral octreotide capsules
Active comparator
RCT phase - Injectables
Injectable somatostatin analogs (octreotide or lanreotide)
Experimental
Combination phase (sub-study)
Octreotide capsules plus cabergoline
Primary outcomes1
Outcomes the sponsor listed as primary.
Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase
Time frame · 62 weeks
Registry 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
Secondary outcomes(6)
Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase
Time frame · Week 62/ End of treatment; EOT
Registry 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)
Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase
Time frame · 62 weeks
Registry 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
Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase
Time frame · 62 weeks
Registry 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)
Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase
Time frame · 62 weeks
Registry 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
Change in IGF-1 Levels in the RCT Phase
Time frame · Change from Week 26 to week 62
Registry 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
Change in GH Levels in the RCT Phase
Time frame · Change from Week 26 to week 62
Registry description
Change in GH levels from the start of the randomized phase through the end of RCT phase.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Week 62/ End of treatment; EOT
Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase
| Group | Value (Participants) |
|---|---|
| RCT Phase - Oral | 36 |
| RCT Phase - Injectables | 27 |
Secondary outcomeCount of participants· 62 weeks
Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase
| Group | Value (Participants) |
|---|---|
| RCT Phase - Oral | 41 |
| RCT Phase - Injectables | 26 |
Secondary outcomeCount of participants· 62 weeks
Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase
| Group | Value (Participants) |
|---|---|
| RCT Phase - Oral | 40 |
| RCT Phase - Injectables | 25 |
Secondary outcomeCount of participants· 62 weeks
Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase
| Group | Value (Participants) |
|---|---|
| RCT Phase - Oral | 34 |
| RCT Phase - Injectables | 18 |
Secondary outcomeMean· Change from Week 26 to week 62
Change in IGF-1 Levels in the RCT Phase
| Group | Value (x Upper limit of normal ("ULN")) | Spread |
|---|---|---|
| RCT Phase - Oral | -0.01 | 0.199 |
| RCT Phase - Injectables | -0.04 | 0.133 |
Secondary outcomeMean· Change from Week 26 to week 62
Change in GH Levels in the RCT Phase
| Group | Value (ng/mL) | Spread |
|---|---|---|
| RCT Phase - Oral | -0.02 | 0.506 |
| RCT Phase - Injectables | 0.27 | 1.219 |
Other pre specified outcomeCount of participants· 62 weeks
Proportion of Patients Reporting Injection Site Reactions in the Acro-TSQ During the RCT Phase
| Group | Value (Participants) |
|---|---|
| RCT Phase - Oral | 0 |
| RCT Phase - Injectables | 17 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Run-in PhaseOral octreotide capsules Octreotide capsules | 0 / 146 | 6 / 146 | 106 / 146 |
| RCT Phase - OralOral octreotide capsules Octreotide capsules | 1 / 55 | 3 / 55 | 39 / 55 |
| RCT Phase - InjectablesInjectable somatostatin analogs (octreotide or lanreotide) Octreotide capsules | 0 / 37 | 3 / 37 | 26 / 37 |
| Combination Phase (Sub-study)Octreotide capsules plus cabergoline Octreotide capsules | 0 / 14 | 0 / 14 | 11 / 14 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Clinical trial · 2015
Corrected7 results
Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial.
Melmed et al. 2015The Journal of clinical endocrinology and metabolismcited by 135
PMID 25664604DOI 10.1210/jc.2014-4113PUB-25664604
Full text at the publisher7 results
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2022
Corrected
Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trial.
Fleseriu et al. 2022The lancet. Diabetes & endocrinologycited by 43
PMID 34953531DOI 10.1016/s2213-8587(21)00296-5PUB-34953531
Rights unknown
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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