Trial · NCT02685709
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
NCT02685709, Phase 3, Completed, Chiasma, Inc.; results first posted 2022-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly. Trials, record NCT02685709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02685709
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
- NCT number
- NCT02685709
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 146 participants, actual
- Lead sponsor
- Chiasma, Inc.
- Conditions
- Acromegaly
- Interventions
- Octreotide capsules
- First posted
- 2016-02-19
- Last updated
- 2022-04-22
- Other registries' IDs
- eudract:2015-002854-11
- Results first posted
- 2022-04-22
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase | 62 weeks | 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 | Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase | Week 62/ End of treatment; EOT | 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) |
| Secondary | Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase | 62 weeks | 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 |
| Secondary | Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase | 62 weeks | 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) |
| Secondary | Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase | 62 weeks | 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 |
| Secondary | Change in IGF-1 Levels in the RCT Phase | Change from Week 26 to week 62 | 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 |
| Secondary | Change in GH Levels in the RCT Phase | Change from Week 26 to week 62 | Change in GH levels from the start of the randomized phase through the end of RCT phase. |
| Other | Proportion of Patients Reporting Injection Site Reactions in the Acro-TSQ During the RCT Phase | 62 weeks | 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. |
| Other | Proportion of Patients Reporting Interference With Daily Activities in Acro-TSQ During the RCT Phase | 62 weeks | 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. |
| Other | Proportion of Patients on Octreotide Capsules Who Are Biochemically Controlled at the End of the RCT Phase- Landmark Analysis | Average of weeks 58 and 62 | 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 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase | 62 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase | Week 62/ End of treatment; EOT | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase | 62 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase | 62 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase | 62 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in IGF-1 Levels in the RCT Phase | Change from Week 26 to week 62 | x Upper limit of normal (ULN) | MEAN | |
| SECONDARY | Change in GH Levels in the RCT Phase | Change from Week 26 to week 62 | ng/mL | MEAN | |
| OTHER_PRE_SPECIFIED | Proportion of Patients Reporting Injection Site Reactions in the Acro-TSQ During the RCT Phase | 62 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Proportion of Patients Reporting Interference With Daily Activities in Acro-TSQ During the RCT Phase | 62 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Proportion of Patients on Octreotide Capsules Who Are Biochemically Controlled at the End of the RCT Phase- Landmark Analysis | Average of weeks 58 and 62 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase | RCT Phase - Oral | 50 | Participants | ||
| Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase | RCT Phase - Injectables | 37 | Participants | ||
| Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase | RCT Phase - Oral | 36 | Participants | ||
| Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase | RCT Phase - Injectables | 27 | Participants | ||
| Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase | RCT Phase - Oral | 41 | Participants | ||
| Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase | RCT Phase - Injectables | 26 | Participants | ||
| Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase | RCT Phase - Oral | 40 | Participants | ||
| Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase | RCT Phase - Injectables | 25 | Participants | ||
| Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase | RCT Phase - Oral | 34 | Participants | ||
| Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase | RCT Phase - Injectables | 18 | Participants |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Phase | STARTED | Run-in Phase | 146 | |
| Run-in Phase | STARTED | RCT Phase - Oral | 0 | |
| Run-in Phase | STARTED | RCT Phase - Injectables | 0 | |
| Run-in Phase | STARTED | Combination Phase (Sub-study) | 0 | |
| Run-in Phase | COMPLETED | Run-in Phase | 116 | |
| Run-in Phase | COMPLETED | RCT Phase - Oral | 0 | |
| Run-in Phase | COMPLETED | RCT Phase - Injectables | 0 | |
| Run-in Phase | COMPLETED | Combination Phase (Sub-study) | 0 | |
| Run-in Phase | NOT COMPLETED | Run-in Phase | 30 | |
| Run-in Phase | NOT COMPLETED | RCT Phase - Oral | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events176
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 | Nausea | Gastrointestinal disorders | Run-in Phase | 32 | 146 | |
| other | Nausea | Gastrointestinal disorders | RCT Phase - Oral | 11 | 55 | |
| other | Nausea | Gastrointestinal disorders | RCT Phase - Injectables | 3 | 37 | |
| other | Nausea | Gastrointestinal disorders | Combination Phase (Sub-study) | 2 | 14 | |
| other | Diarrhea | Gastrointestinal disorders | Run-in Phase | 22 | 146 | |
| other | Diarrhea | Gastrointestinal disorders | RCT Phase - Oral | 6 | 55 | |
| other | Diarrhea | Gastrointestinal disorders | RCT Phase - Injectables | 5 | 37 | |
| other | Diarrhea | Gastrointestinal disorders | Combination Phase (Sub-study) | 1 | 14 | |
| other | Flatulence | Gastrointestinal disorders | Run-in Phase | 14 | 146 | |
| other | Flatulence | Gastrointestinal disorders | RCT Phase - Oral | 14 | 55 |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-in Phase | 0 | 146 |
| Total, all-cause mortality | RCT Phase - Oral | 1 | 55 |
| Total, all-cause mortality | RCT Phase - Injectables | 0 | 37 |
| Total, all-cause mortality | Combination Phase (Sub-study) | 0 | 14 |
| Total, other adverse events | Run-in Phase | 106 | 146 |
| Total, other adverse events | RCT Phase - Oral | 39 | 55 |
| Total, other adverse events | RCT Phase - Injectables | 26 | 37 |
| Total, other adverse events | Combination Phase (Sub-study) | 11 | 14 |
| Total, serious adverse events | Run-in Phase | 6 | 146 |
| Total, serious adverse events | RCT Phase - Oral | 3 | 55 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| RCT Phase - Oral vs RCT Phase - Injectables: Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase | Trial comparisons |
| RCT Phase - Oral vs RCT Phase - Injectables: Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase | Trial comparisons |
| RCT Phase - Oral vs RCT Phase - Injectables: Proportion of Patients on Octreotide Capsules Who Are Biochemically Controlled at the End of the RCT Phase- Landmark Analysis | Trial comparisons |
| RCT Phase - Oral vs RCT Phase - Injectables: Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase | Trial comparisons |
| RCT Phase - Oral vs RCT Phase - Injectables: Proportion of Patients Reporting Interference With Daily Activities in Acro-TSQ During the RCT Phase | Trial comparisons |
| RCT Phase - Oral vs RCT Phase - Injectables: Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase | Trial comparisons |
| RCT Phase - Oral vs RCT Phase - Injectables: Proportion of Patients Reporting Injection Site Reactions in the Acro-TSQ During the RCT Phase | Trial comparisons |
| RCT Phase - Oral vs RCT Phase - Injectables: Proportion of Week 26 Responders on Octreotide Capsules Who Are Biochemically Controlled at the End of the RCT Phase- Landmark Sensitivity Analysis | Trial comparisons |
| RCT Phase - Oral vs RCT Phase - Injectables: Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase | 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.
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GET https://conductscience.org/api/trials/v1/NCT02685709/results?page=2