Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure (ANGIOPAS)
The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some cases bleeding remaining inaccessible to endoscopic treatment. Several observational studies suggest that treatment with somatostatin analogue would reduce transfusion requirements in patients with recurrent bleeding due to angiodysplasia.
No randomized studies are available. The main objective of this study multicenter, prospective, randomized, was to assess the transfusion requirements in patients with recurrent bleeding due to angiodysplasia treated by a new analogue of somatostatin, Pasireotide, versus placebo.
Patients with recurrent gastrointestinal bleeding related to angiodysplasias, endoscopic treatment failure, with a need transfusion at least 6 red blood cells during the 6 months prior to inclusion could be randomized to receive monthly intramuscular injection of Pasireotide 60 mg or placebo for a period of 6 months. Patients were then followed for an additional 6 months after stopping treatment. A test monthly clinical and laboratory was performed during the six months of treatment then quarterly during the six months of surveillance.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Trial Evaluating the Efficiency of Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure|
- number of red blood cells transfused [ Time Frame: at 6 months ] [ Designated as safety issue: No ]number of red blood cells transfused at 6 months in patients treated with pasireotide or placebo.
|Study Start Date:||March 2012|
|Study Completion Date:||October 2015|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
1 injection per month during 6 months of the placebo product
Vehicule injection per month during 6 months
Active Comparator: Pasireotide
1 injection per month during 6 months of the Pasireotide LP (60mg/injection)
60 mg per month of the Pasireotide during 6 months
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02622906
|Société Française d'Endoscopie Digestive (SFED)|
|Paris, France, 75006|
|Principal Investigator:||Robert BENAMOUZIG||Société Française d'Endoscopie Digestive|