NCT03252353

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Chiasma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).

Detailed description

This is a double blind, randomized study that assesses the efficacy and safety of octreotide capsules vs. placebo. Eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks. At the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year. Patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules. This study received agreement from the FDA, under a special protocol assessment.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	octreotide capsules	octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)
DRUG	Matching placebo	Matching placebo capsules

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-06-13
• Completion: 2022-05-01
• First posted: 2017-08-17
• Last updated: 2020-11-23
• Results posted: 2020-10-19

Locations

60 sites across 17 countries: United States, Australia, Bulgaria, Canada, Denmark, Germany, Hungary, Israel, Italy, Latvia, Netherlands, New Zealand, Poland, Slovenia, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study