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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00729313
First received: August 4, 2008
Last updated: June 18, 2012
Last verified: June 2012

August 4, 2008
June 18, 2012
April 2000
April 2005   (final data collection date for primary outcome measure)
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours. [ Time Frame: Fistula drainage volume on 3rd day. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00729313 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Pancreatic or duodenal and small intestine fistula closing rate within D60 [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
  • Number of injections received by each patient [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Percentage of fistula recurrence during the follow-up period [ Time Frame: Duration of follow-up period for each patient is of 1 month ] [ Designated as safety issue: No ]
  • Percentage of mortality in each group [ Time Frame: End of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Digestive Fistulae
  • Drug: Lanreotide microparticles
  • Drug: Placebo
  • 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.

    Intervention: Drug: Lanreotide microparticles
  • 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.

    Intervention: Drug: Placebo
Gayral F, Campion JP, Regimbeau JM, Blumberg J, Maisonobe P, Topart P, Wind P; Lanreotide Digestive Fistula. Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae. Ann Surg. 2009 Dec;250(6):872-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
April 2005
April 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Russian Federation
 
NCT00729313
E-54-52030-053
No
Joelle Blumberg, Ipsen
Ipsen
Not Provided
Study Director: Joëlle Blumberg, MD Ipsen
Ipsen
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP