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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT00729313 (opens ClinicalTrials.gov in a new tab)Other idE-54-52030-053
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
111 participants (actual)
Sponsor
Ipsen · Industry
Design
Randomized · Double masking
Countries
2 countries

France, Russia

Start
Apr 2000
Primary completion
Apr 2005
Completion
Apr 2005
First posted
7 Aug 2008 (estimated)
Last update posted
4 Mar 2019
Conditions
Digestive Fistulae

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2000200120022003200420052006
  1. Ph 3

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

    NCT00729313

    Apr 2000 to Apr 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Lanreotide microparticlesDrug
  • PlaceboDrug

Arms2

  • Experimental

    1

    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.

  • Placebo comparator

    2

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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 outcomes(5)

  1. 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

  2. Pancreatic or duodenal and small intestine fistula closing rate within D60

    Time frame · Day 60

  3. Number of injections received by each patient

    Time frame · End of study

  4. Percentage of fistula recurrence during the follow-up period

    Time frame · Duration of follow-up period for each patient is of 1 month

  5. Percentage of mortality in each group

    Time frame · End of study

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2009

4 results

Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae.

Gayral et al. 2009Annals of surgerycited by 34

PMID 19953707DOI 10.1097/sla.0b013e3181b2489fPUB-19953707

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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