Trial · NCT01412424
Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly
NCT01412424, Phase 3, Completed, Chiasma, Inc.; results first posted 2015-12-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly. Trials, record NCT01412424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01412424
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly
- NCT number
- NCT01412424
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 155 participants, actual
- Lead sponsor
- Chiasma, Inc.
- Conditions
- Acromegaly
- Interventions
- Octreotide capsules
- First posted
- 2011-08-09
- Last updated
- 2017-08-17
- Results first posted
- 2015-12-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Responders at the End of the Core Treatment Period | End of the core treatment period (up to 7 months) | A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration \< 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration \< 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. |
| Primary | Percentage of Responders at the End of the Extension Treatment Period | End of the extension treatment period (up to 13 months) | A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration \< 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration \< 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. |
| Secondary | Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period | Baseline and the end of the core treatment period (up to 7 months) | Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at Baseline and at the end of the core treatment period (ECTP): IGF-1 \< 1.3 times the upper limit of normal (ULN) and GH \< 5.0 ng/mL, IGF-1 \< 1.3 times ULN and GH \< 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 1.0 ng/mL, IGF-1 \< 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH \< 5.0 ng/mL, GH \< 2.5 ng/mL, GH \< 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH \< 2.5 ng/mL, IGF-1 \< 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. |
| Secondary | Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period | Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months) | Maintenance of response during the fixed dose phase of the core treatment period was defined as the percentage of participants with an insulin-like growth factor-1 (IGF-1) concentration \< 1.3 times the upper limit of normal at the beginning of the fixed dose phase of the core treatment period and at the end of the core treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed. |
| Secondary | Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period | Beginning and the end of the extension treatment period (up to 6 months) | Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at the beginning (BETP) and at the end (EETP) of the extension treatment period: IGF-1 \< 1.3 times the upper level of normal (ULN) and GH \< 5.0 ng/mL, IGF-1 \< 1.3 times ULN and GH \< 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 1.0 ng/mL, IGF-1 \< 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH \< 5.0 ng/mL, GH \< 2.5 ng/mL, GH \< 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH \< 2.5 ng/mL, IGF-1 \< 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed. |
| Secondary | Maintenance of Response During the Extension Treatment Period | Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months) | Maintenance of an insulin-like growth factor-1 (IGF-1) response during the extension treatment period was defined as the percentage of participants with an IGF-1 concentration \< 1.3 times the upper limit of normal at the beginning of the extension treatment period and at the end of the extension treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed. |
| Secondary | Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period | Baseline and the end of the extension treatment period (up to 13 months) | The severity (absent, mild, moderate, severe) of the 5 acromegaly symptoms headache, perspiration, asthenia, swelling of extremities, and joint pain was assessed at Baseline and at the end of the extension treatment period. The percentage of participants with improved or maintained (no change) acromegaly symptoms from Baseline at the end of the extension treatment period is reported. |
| Secondary | Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period | Baseline and the end of the extension treatment period (up to 13 months) | Reported is the percentage of participants who had ≥ 1, 2, or 3 of the 5 symptoms of acromegaly (headaches, perspiration, asthenia, swelling of extremities, or joint pain) of any severity (mild, moderate, or severe). This was a post hoc analysis. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Responders at the End of the Core Treatment Period | End of the core treatment period (up to 7 months) | Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide. | Percentage of responders | NUMBER |
| PRIMARY | Percentage of Responders at the End of the Extension Treatment Period | End of the extension treatment period (up to 13 months) | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Percentage of responders | NUMBER |
| SECONDARY | Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period | Baseline and the end of the core treatment period (up to 7 months) | Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide. | Percentage of participants | NUMBER |
| SECONDARY | Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period | Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months) | Fixed dose population: All enrolled participants who received any amount of study drug, who had at least 1 IGF-1 or GH assessment after the first dose of octreotide, and who entered the fixed dose phase of the core treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period | Beginning and the end of the extension treatment period (up to 6 months) | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Maintenance of Response During the Extension Treatment Period | Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months) | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period | Baseline and the end of the extension treatment period (up to 13 months) | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period | Baseline and the end of the extension treatment period (up to 13 months) | Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Responders at the End of the Core Treatment Period | Octreotide 40 mg | 86.9 | 95% Confidence Interval 83.0 to 98.1 | Percentage of responders | |
| Percentage of Responders at the End of the Core Treatment Period | Octreotide 60 mg | 66.7 | 95% Confidence Interval 48.2 to 82.0 | Percentage of responders | |
| Percentage of Responders at the End of the Core Treatment Period | Octreotide 80 mg | 40.4 | 95% Confidence Interval 27.6 to 54.2 | Percentage of responders | |
| Percentage of Responders at the End of the Core Treatment Period | Octreotide 40, 60, or 80 mg - All Participants | 64.9 | 95% Confidence Interval 58.4 to 74.2 | Percentage of responders | |
| Percentage of Responders at the End of the Extension Treatment Period | Octreotide Capsules | 78.4 | 95% Confidence Interval 68.4 to 86.5 | Percentage of responders | |
| Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period | Octreotide Capsules | IGF-1 < 1.3 & GH < 5.0: Baseline | 91.4 | Percentage of participants | |
| Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period | Octreotide Capsules | IGF-1 < 1.3 & GH < 5.0: ECTP | 65.6 | Percentage of participants | |
| Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period | Octreotide Capsules | IGF-1 < 1.3 & GH < 1.0: Baseline | 62.9 | Percentage of participants | |
| Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period | Octreotide Capsules | IGF-1 < 1.3 & GH < 1.0: ECTP | 53.0 | Percentage of participants | |
| Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period | Octreotide Capsules | IGF-1 ≤ 1.0 & GH < 5.0: Baseline | 63.6 | Percentage of participants |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Treatment Period | STARTED | Octreotide Capsules | 155 | |
| Core Treatment Period | COMPLETED | Octreotide Capsules | 102 | |
| Core Treatment Period | NOT COMPLETED | Octreotide Capsules | 53 | |
| Extension Treatment Period | STARTED | Octreotide Capsules | 88 | |
| Extension Treatment Period | COMPLETED | Octreotide Capsules | 82 | |
| Extension Treatment Period | NOT COMPLETED | Octreotide Capsules | 6 |
Source ClinicalTrials.gov
Adverse events177
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 distension | Gastrointestinal disorders | Octreotide 40 mg | 7 | 155 | |
| other | Abdominal distension | Gastrointestinal disorders | Octreotide 60 mg | 4 | 91 | |
| other | Abdominal distension | Gastrointestinal disorders | Octreotide 80 mg | 1 | 58 | |
| other | Abdominal pain | Gastrointestinal disorders | Octreotide 40 mg | 5 | 155 | |
| other | Abdominal pain | Gastrointestinal disorders | Octreotide 60 mg | 7 | 91 | |
| other | Abdominal pain | Gastrointestinal disorders | Octreotide 80 mg | 1 | 58 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Octreotide 40 mg | 10 | 155 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Octreotide 60 mg | 2 | 91 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Octreotide 80 mg | 3 | 58 | |
| other | Diarrhoea | Gastrointestinal disorders | Octreotide 40 mg | 18 | 155 |
1 to 10 of 177Source ClinicalTrials.gov
See all 177 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octreotide 40 mg | 1 | 155 |
| Total, all-cause mortality | Octreotide 60 mg | 0 | 91 |
| Total, all-cause mortality | Octreotide 80 mg | 1 | 58 |
| Total, other adverse events | Octreotide 40 mg | 103 | 155 |
| Total, other adverse events | Octreotide 60 mg | 51 | 91 |
| Total, other adverse events | Octreotide 80 mg | 31 | 58 |
| Total, serious adverse events | Octreotide 40 mg | 9 | 155 |
| Total, serious adverse events | Octreotide 60 mg | 7 | 91 |
| Total, serious adverse events | Octreotide 80 mg | 8 | 58 |
Source ClinicalTrials.gov
Papers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01412424
GET https://conductscience.org/api/trials/v1/NCT01412424/results?page=2