At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 28 enrolled
Drug / intervention
Octreotide acetate 30 mg suspensiondrug
Likely dose
Octreotide acetate 30 mg suspensionfrom 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 Randomised, Open-label, Multicenter Study Comparing the Efficacy and Safety of Medical Treatment With Octreotide Acetate 30 mg Administered Every 21 Days for 6 Months With That of Octreotide Acetate 60 mg Administered Every 28 Days for 6 Months in Acromegalic Patients With Uncontrolled Disease
In Brief
A Phase 3 clinical trial evaluating Octreotide acetate 30 mg suspension for Acromegaly. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2005
First PostedSep 2006
Primary CompletionOct 2007
TodayJul 2026
First PostedSep 7, 2006
Enrollment StartDec 1, 2005
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.8 years ago
Interventions
Octreotide acetate 30 mg suspensiondrug
Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.