Trial · NCT03252353
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
NCT03252353, Phase 3, Unknown, Chiasma, Inc.; results first posted 2020-10-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly. Trials, record NCT03252353. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03252353
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
- NCT number
- NCT03252353
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 56 participants, actual
- Lead sponsor
- Chiasma, Inc.
- Conditions
- Acromegaly
- Interventions
- octreotide capsules, Matching placebo
- First posted
- 2017-08-17
- Last updated
- 2020-11-23
- Results first posted
- 2020-10-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period. | Week 36 | Maintenance of response was defined by using the average IGF-1 level of the last 2 available assessments in the DPC period. If the average IGF-1 is ≤ 1×ULN, a patient was classified as a responder (i.e., maintained their biochemical response). If the average IGF-1 is \> 1×ULN, a patient was classified as a non-responder. Patients who discontinue study medication during the DPC period for any reason was classified as non-responders for the primary analysis, regardless of their IGF-1 values. |
| Secondary | Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period | Week 36 | Maintenance of GH response was defined as having mean Growth Hormone (5 measurements 30 minutes apart) \< 2.5 ng/mL at the end of the double blind placebo controlled period, out of those who were responders on Somatostatin Receptor Ligands (SRLs) injections at Screening. |
| Secondary | Number of Patients Who Begin Rescue Treatment | Week 36 | Number of Patients who Began Rescue Treatment Prior to and Including Week 36 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period. | Week 36 | Number of Patients who Maintained Their Biochemical Response at the End of the DPC Period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period | Week 36 | Number of patients who maintain Growth Hormone (GH) response at the end of the double blind placebo controlled period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Begin Rescue Treatment | Week 36 | The number of patients who began rescue treatment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period. | Octreotide Capsules | 16 | Participants | ||
| Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period. | Matching Placebo | 5 | Participants | ||
| Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period | Octreotide Capsules | 21 | Participants | ||
| Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period | Placebo | 7 | Participants | ||
| Number of Patients Who Begin Rescue Treatment | Octreotide Capsules | 7 | Participants | ||
| Number of Patients Who Begin Rescue Treatment | Placebo | 19 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Octreotide Capsules | 28 | |
| Overall Study | STARTED | Matching Placebo | 28 | |
| Overall Study | COMPLETED | Octreotide Capsules | 28 | |
| Overall Study | COMPLETED | Matching Placebo | 28 | |
| Overall Study | NOT COMPLETED | Octreotide Capsules | 0 | |
| Overall Study | NOT COMPLETED | Matching Placebo | 0 |
Source ClinicalTrials.gov
Adverse events86
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Octreotide Capsules | 4 | 28 | 4 |
| other | Abdominal discomfort | Gastrointestinal disorders | Matching Placebo | 3 | 28 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Octreotide Capsules | 2 | 28 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Matching Placebo | 2 | 28 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Octreotide Capsules | 1 | 28 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Matching Placebo | 3 | 28 | 3 |
| other | Constipation | Gastrointestinal disorders | Octreotide Capsules | 3 | 28 | 4 |
| other | Constipation | Gastrointestinal disorders | Matching Placebo | 4 | 28 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Octreotide Capsules | 8 | 28 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Matching Placebo | 6 | 28 | 6 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octreotide Capsules | 0 | 28 |
| Total, all-cause mortality | Matching Placebo | 0 | 28 |
| Total, other adverse events | Octreotide Capsules | 28 | 28 |
| Total, other adverse events | Matching Placebo | 27 | 28 |
| Total, serious adverse events | Octreotide Capsules | 2 | 28 |
| Total, serious adverse events | Matching Placebo | 1 | 28 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Octreotide Capsules vs Placebo: Number of Patients Who Begin Rescue Treatment | Trial comparisons |
| Octreotide Capsules vs Placebo: Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period | Trial comparisons |
| Octreotide Capsules vs Matching Placebo: Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period. | Trial comparisons |
| Octreotide Capsules vs Matching Placebo: deaths from any cause | Trial comparisons |
| Octreotide Capsules vs Matching Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03252353
GET https://conductscience.org/api/trials/v1/NCT03252353/events?page=2