Status:
UNKNOWN
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
Lead Sponsor:
Chiasma, Inc.
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
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 b...
Eligibility Criteria
Inclusion
- Documented evidence of active acromegaly
- Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy
- Biochemically controlled
Exclusion
- Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as indicated in the label
- Pituitary surgery within six months
- Conventional or stereotactic pituitary radiotherapy any time in the past
- Patients who previously participated in CH-ACM-01 or OOC-ACM-302
- Any clinically significant uncontrolled concomitant disease
- Symptomatic cholelithiasis
- Pegvisomant, within 24 weeks
- Dopamine agonists, within 12 weeks
- Pasireotide, within 24 weeks
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03252353
Start Date
September 1 2017
End Date
May 1 2022
Last Update
November 23 2020
Active Locations (60)
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1
Keck Medical Center of University of Southern California
Los Angeles, California, United States, 90033
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
UCLA Medical Center
Los Angeles, California, United States, 90095
4
Stanford University School of Medicine
Palo Alto, California, United States, 94304