A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands (MPOWERED)

NCT02685709 Phase 3 COMPLETED Results posted

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).

Details

Lead sponsor	Chiasma, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	146
Start date	2016-02
Completion	2021-08

Conditions

• Acromegaly

Interventions

• Octreotide capsules

Primary outcomes

• Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase — 62 weeks
  Proportion of patients who are biochemically controlled throughout the RCT phase. A patient was considered biochemically controlled if IGF-1 Time Weighted Average (TWA) during the RCT phase is \<1.3 ULN

Countries

United States, Austria, France, Germany, Hungary, Italy, Lithuania, Poland, Romania, Russia, Serbia, Spain, United Kingdom