At a glance
ClinicalIndex Comparison RecordPhase 3Unknown· 56 enrolled
Drug / intervention
octreotide capsules +1 moredrug
Likely dose
octreotide capsules 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating octreotide capsules and Matching placebo for Acromegaly. Targeting 56 participants across 60 sites in 17 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesAustralia, Bulgaria, Canada, Denmark, Germany, Hungary, Israel, Italy, Latvia, Netherlands, New Zealand, Poland, Slovenia, Sweden, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3UnknownOverdue
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionJun 2019
Study CompletionMay 2022
TodayJul 2026
First PostedAug 17, 2017
Enrollment StartSep 1, 2017
Primary CompletionJun 13, 2019
Study CompletionMay 1, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.9 years ago
Interventions
octreotide capsulesdrug
octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)
Matching placebodrug
Matching placebo capsules