Phase 3
N=146
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Acromegaly
Bottom Line
View on ClinicalTrials.gov: NCT02685709 ↗Enrolled (actual)
146
Serious AEs
4.8%
Results posted
Apr 2022
Primary outcome: Primary: Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase — 50; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Octreotide capsules (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chiasma, Inc.
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase |
50; 37 | — |
| SECONDARY Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase |
36; 27 | — |
| SECONDARY Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase |
41; 26 | — |
| SECONDARY Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase |
40; 25 | — |
| SECONDARY Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase |
34; 18 | — |
| SECONDARY Change in IGF-1 Levels in the RCT Phase |
-0.01; -0.04 | — |
| SECONDARY Change in GH Levels in the RCT Phase |
-0.02; 0.27 | — |
Summary
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref).
The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs).
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of acromegaly
- Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months
- Biochemical control (IGF -1 8 weeks.
- Pituitary radiotherapy within 5 years
- Pituitary surgery within six months
- Patients who previously participated in CH-ACM-01 study
- Any clinically significant uncontrolled concomitant disease
- Symptomatic cholelithiasis
- Previous treatment with:
- Pegvisomant, within 12 weeks
- Dopamine agonists, within 6 weeks
- Pasireotide, within 12 weeks
Data sourced from ClinicalTrials.gov (NCT02685709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.