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

Ipsen

Status and phase: Completed; Phase 3

Conditions: Digestive Fistulae

Treatments: Drug: Placebo; Drug: Lanreotide microparticles

Study type: Interventional

Funder types: Industry

Identifiers

NCT00729313

E-54-52030-053

Details and patient eligibility

About

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

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Drug: Lanreotide 30 mg microparticle formulation One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of lanreotide 30 mg microparticle formulation every 10 days): according to the patient's treatment response at 72h For non-responders patients lanreotide will be stopped.

Treatment:

Drug: Lanreotide microparticles

2

Placebo Comparator group

Description:

One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h. Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment.

Treatment:

Drug: Placebo