Status:
COMPLETED
Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
Lead Sponsor:
Ipsen
Conditions:
Digestive Fistulae
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00729313
Start Date
April 1 2000
End Date
April 1 2005
Last Update
March 4 2019
Active Locations (19)
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1
Hôpital Nord
Amiens, France, 80054
2
CHU J. Minjoz
Besançon, France, 25031
3
Hôpital Avicenne
Bobigny, France, 93009
4
Hôpital de la Cavale Blanche
Brest, France, 29609