NCT00729313

Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae

A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.

Detailed description

The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.

Conditions

• Digestive Fistulae

Interventions

Type	Name	Description
DRUG	Lanreotide microparticles
DRUG	Placebo

Timeline

• Start date: 2000-04-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2008-08-07
• Last updated: 2019-03-04

Locations

19 sites across 2 countries: France, Russia