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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Angiopeptin; Lanreotide; Somatostatin

Criteria

Inclusion Criteria:

• Patient with pancreatic, duodenal, or small intestine fistula

• Patient with simple, externalised fistula

• Patient with fistula for which a medical conservative treatment is considered

• Patient with:

• for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively,

• for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days

Exclusion Criteria:

• Patient expected to require a surgical treatment of the fistula during the study

• Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies.

• Patient receiving long-term corticotherapy

• Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month.

• Patient having previously undergone a transplant