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NCT04076462 · ClinicalTrials.gov registry record · Phase 3
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly
A Phase 3 study of Acromegaly, sponsored by Camurus AB.
- Completed
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
- 20
- Study locations
NCT04076462: Completed Phase 3 study of Acromegaly, sponsored by Camurus AB.
NCT04076462 is a Phase 3 study of Acromegaly that has completed, run by Camurus AB. The registered enrollment target is 72 participants, below the 96-participant average among 13 other Acromegaly trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04076462, a Phase 3 study of Acromegaly, has completed, sponsored by Camurus AB.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.
Primary Outcome
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 switch
Conditions Studied
Interventions
- DRUG Matching placebo
- DRUG CAM2029 (octreotide subcutaneous depot)
Study Locations (20)
Other
- Universitätsklinikum Essen - Essen
- Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin - Frankfurt
- Universitätsklinikum Freiburg - Freiburg im Breisgau
- LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV - Munich
- Medicover Neuroendokrinologie - Munich
- Medicover Oldenburg MVZ - Oldenburg
- General Hospital of Athens "Laiko", Endocrinology University Clinic - Athens
- Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism - Athens
California
- UCLA Department of Medicine Division of Endocrinology - Los Angeles
- Stanford University Medical Center - Palo Alto
Pennsylvania
- Thomas Jefferson University - Philadelphia
- Allegheny Endocrinology Associates - Pittsburgh
Florida
- Prufen Clinical Research LLC - Miami
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University in St. Louis, School of Medicine - St Louis
Nevada
- Palm Research Center - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2019-08-19 |
| Est. Completion | 2023-05-02 |
| Phase | Phase 3 |
What the finished NCT04076462 record still lists
NCT04076462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 96-participant average among 13 other Acromegaly trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Acromegaly appearing as the primary indexed condition, and to 2 interventions - of which Matching placebo is the first listed.
NCT04076462 names 20 study sites across 11 states, led by Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04076462 about?
NCT04076462 is a clinical study titled "A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly". The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.
What is the current status of trial NCT04076462?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2019-08-19. Estimated completion is 2023-05-02.
What conditions does trial NCT04076462 study?
This clinical trial studies the following conditions: Acromegaly.
What interventions are being tested in trial NCT04076462?
The interventions under investigation include: Matching placebo (DRUG), CAM2029 (octreotide subcutaneous depot) (DRUG).
Who is sponsoring clinical trial NCT04076462?
This trial is sponsored by Camurus AB, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04076462 being conducted?
This trial has 20 study locations across California, Florida, Michigan, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acromegaly
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04076462's enrollment target sits among peer trials
72 7th of 13 higher than 7 of 13 other Acromegaly trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acromegaly trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
RECRUITING · Phase 3
-
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
ACTIVE NOT RECRUITING · Phase 3
-
ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly
RECRUITING · Phase 2
-
Diet in the Management of Acromegaly
RECRUITING · NA
-
Study of MAR002 in Healthy Men
RECRUITING · Phase 1
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