Trial · NCT04076462
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
NCT04076462, Phase 3, Completed, Camurus AB
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly. Trials, record NCT04076462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04076462
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
- NCT number
- NCT04076462
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 72 participants, actual
- Lead sponsor
- Camurus AB
- Conditions
- Acromegaly
- Interventions
- CAM2029 (octreotide subcutaneous depot), Matching placebo
- First posted
- 2019-09-03
- Last updated
- 2026-08-20
- Other registries' IDs
- eudract:2019-001191-11
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Mean Insulin-like Growth Factor -1 (IGF-1) Levels ≤1 x Upper Limit of Normal (ULN) at Week 22/24 | Week 22 and 24 | If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the intention-to-treat (ITT) analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants". |
| Secondary | Proportion of Participants With Mean IGF-1 Levels ≤1x Upper Limit or Normal (ULN) at Week 22/24, Including Participants With Dose Reduction | Week 22 and 24 | First key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample. A composite strategy was assumed for intercurrent events, and a participant was considered as a non-responder if they discontinued IMP and/or was switched to rescue medication. For this endpoint, a patient who had their dose reduced was not directly classified as a non-responder. No participant had their dose reduced during the trial. ULN was derived from the participant's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants" |
| Secondary | Proportion of Participants With Mean IGF-1 Levels ≤1xULN at Week 22/Week 24 and Mean Growth Hormone (GH) Levels <2.5 µg/L at Week 24 | Week 22 and 24 | Second key secondary endpoint. If one of the IGF-1 values at Week 22 or Week 24 was missing, the other value was used to define a responder/non-responder in the analysis. The variable of interest was considered missing only if no IGF-1 value could be obtained from either the Week 22 or the Week 24 sample or no GH value at Week 24. A composite strategy was assumed for intercurrent events, and a patient was considered as a non-responder if they discontinued IMP or had the dose reduced prior to Week 22 (regardless of IGF-1 values), and/or was switched to rescue medication. ULN was based on the patient's sex and age at screening. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of responders was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants". |
| Secondary | Proportion of Participants With Mean GH Levels <2.5 µg/L at Week 24 | Week 24 | For the responder analysis of mean GH \<2.5 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants". |
| Secondary | Proportion of Participants With Mean GH Levels <1.0 µg/L at Week 24 | Week 24 | For the responder analysis of mean GH \<1.0 µg/L at Week 24, a composite strategy was assumed for intercurrent events. A participant was considered as a non-responder if they discontinued IMP, or had the dose reduced prior to Week 24 (regardless of mean GH values), and/or was switched to rescue medication. In order to account for all participants in the ITT analysis set, multiple imputation was applied. The mean proportion of participants was calculated as an average of responders across the imputed datasets. The resulting proportion was multiplied by 100 to present "Percentage of participants". |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Week 0 to 24 | A treatment emergent adverse event was defined as an adverse event that occurred during or after the first administration of the IMP to the end of trial visit or the next dose of any acromegaly treatment, whichever came first. |
| Secondary | Proportion of Participants/Partners Declared Competent by a Healthcare Professional to Administer Intervention | Week 0 to 20 and Week 24 | During participants'/partners' first three attempts during the trial period of 24 weeks whenever these visits took place. Percentages were based on those who opted for self-/partner-administration. |
| Secondary | Octreotide Plasma Concentrations Over Time | Week 0 to 24 | Plasma samples were taken pre-dose on dosing days. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT04076462
GET https://conductscience.org/api/trials/v1/NCT04076462/registered