NCT00765323

Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.

Detailed description

This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1 to Week 24), and the Extension Phase (Post Week 24 to Week 48). Primary efficacy and safety will be determined from the Primary Treatment Phase. Eligible patients will be randomized during the Primary Treatment Phase; in a 3 to 1 ratio to receive 6 months of open-label treatment with either the 84 mg octreotide implant or monthy Injections of S-LAR. Each patient in this study will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits. All patients who complete the Primary Treatment Phase and who continue to meet eligibility criteria will be offered the opportunity to enter the Extension Phase; patients entering the Extension Phase will be treated with an octreotide implant for 6 months.During the Extension Phase, patients will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Octreotide Implant	84 mg octreotide subcutaneous implant for 6 months
DRUG	Sandostatin LAR Depot	Injections of Sandostatin LAR (dose range \~10-40 mg every 28 days)

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-02-01
• Completion: 2011-06-01
• First posted: 2008-10-02
• Last updated: 2013-09-27

Locations

47 sites across 9 countries: United States, Czechia, Germany, Hungary, Poland, Russia, Serbia, Slovakia, Spain