Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure (ANGIOPAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02622906|
Recruitment Status : Completed
First Posted : December 7, 2015
Last Update Posted : December 7, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Angiodysplasia||Drug: Pasireotide Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Phase II Trial Evaluating the Efficiency of Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||October 2015|
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
- number of red blood cells transfused [ Time Frame: at 6 months ]number of red blood cells transfused at 6 months in patients treated with pasireotide or placebo.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622906
|Société Française d'Endoscopie Digestive (SFED)|
|Paris, France, 75006|
|Principal Investigator:||Robert BENAMOUZIG||Société Française d'Endoscopie Digestive|