NCT00216372

Efficacy and Safety of Lanreotide Microparticles as Palliative Treatment in Peritoneal Carcinomatosis

Phase III, Multicentre, Randomised, Double-blind, Comparative Study to Assess the Efficacy and Safety of Lanreotide 30 mg Versus Placebo as a Palliative Treatment of Clinical Symptoms Associated With Intestinal Obstruction Due to Peritoneal Carcinomatosis in Inoperable Patients.

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

Summary

The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.

Conditions

• Intestinal Obstruction
• Carcinoma
• Peritoneal Neoplasms

Interventions

Type	Name	Description
DRUG	Lanreotide (microparticle formulation)	A single 30 mg intra-muscular injection on day 0. The duration of the blinded phase is 10 days. Patients may enter the open phase where they receive 30 mg intra-muscular injections, every 10 days until investigator/or patient decide to stop treatment.
OTHER	Placebo	A single intra-muscular injection on day 0.

Timeline

• Start date: 2003-09-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2005-09-22
• Last updated: 2020-11-05

Locations

53 sites across 3 countries: Belgium, France, Netherlands