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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00729313
• Date of registration: 04/08/2008
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
• Scientific title: 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
• Date of first enrolment: April 2000
• Target sample size: 111
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00729313
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

France, Russian Federation

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Digestive Fistulae

Intervention(s)

Drug: Placebo

Drug: Lanreotide microparticles

Primary Outcome(s)

Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours. [Time Frame: Fistula drainage volume on 3rd day.]

Secondary Outcome(s)

Percentage of mortality in each group [Time Frame: End of study]

Pancreatic or duodenal and small intestine fistula closing rate within D60 [Time Frame: Day 60]

Percentage of fistula recurrence during the follow-up period [Time Frame: Duration of follow-up period for each patient is of 1 month]

Closure time of digestive fistulae will be defined by the interval between D0 (day of the first injection) and the date of spontaneous closure of the fistula. [Time Frame: Day 60]

Number of injections received by each patient [Time Frame: End of study]

Secondary ID(s)

E-54-52030-053

Source(s) of Monetary Support

Please refer to primary and secondary sponsors