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 (OPTIMAL)

NCT03252353 Phase 3 UNKNOWN Results posted

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).

Details

Lead sponsor	Chiasma, Inc.
Phase	Phase 3
Status	UNKNOWN
Enrolment	56
Start date	2017-09-01
Completion	2022-05

Conditions

• Acromegaly

Interventions

• octreotide capsules
• Matching placebo

Primary outcomes

• Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period. — Week 36
  Maintenance of response was defined by using the average IGF-1 level of the last 2 available assessments in the DPC period. If the average IGF-1 is ≤ 1×ULN, a patient was classified as a responder (i.e., maintained their biochemical response). If the average IGF-1 is \> 1×ULN, a patient was classified as a non-responder. Patients who discontinue study medication during the DPC period for any reason was classified as non-responders for the primary analysis, regardless of their IGF-1 values.

Countries

United States, Australia, Bulgaria, Canada, Denmark, Germany, Hungary, Israel, Italy, Latvia, Netherlands, New Zealand, Poland, Slovenia, Sweden, Turkey (Türkiye), United Kingdom