NCT00372697

Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Octreotide acetate 30 mg suspension	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.

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-09-07
• Last updated: 2011-05-17
• Results posted: 2011-05-17

Locations

1 site across 1 country: Italy