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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
Sponsor:
Information provided by (Responsible Party):
Robert Benamouzig, Hospital Avicenne

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide

Arm Intervention/treatment
Placebo Comparator: Placebo
1 injection per month during 6 months of the placebo product
Drug: Placebo
Vehicule injection per month during 6 months

Active Comparator: Pasireotide
1 injection per month during 6 months of the Pasireotide LP (60mg/injection)
Drug: Pasireotide
60 mg per month of the Pasireotide during 6 months




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Angiodysplasia of the stomach, small intestine or colon confirmed by endoscopy.
  2. 6 or more of packed red cells unit transfusion during the 6 months prior inclusion.
  3. Failed endoscopic therapy or cons-indication for endoscopic treatment.
  4. Patient affiliated to a social security insurance.
  5. Age > 18 years.
  6. Consent signed by the patient.

Exclusion Criteria:

  1. Treatment with somatostatin analogue in the 6 months prior to inclusion
  2. Symptomatic cholelithiasis
  3. Rendu-Osler disease
  4. Uncontrolled diabetes (HbA1c > 8%)
  5. Breaking of the esophageal varicose veins bleeding older than six months.
  6. Patients treated with anti vitamin K at baseline and during the study.
  7. Patients with (AST, ALT> 2 ULN) and / or total bilirubin > 1.5 ULN.
  8. TP < 50%, platelets <75 000/mm3, aPTT> 1.5 times the control
  9. Uncontrolled heart disease: myocardial infarction within 6 months, status epilepticus angina, congestive heart failure grade III and NYHA, ventricular tachycardia, ventricular fibrillation, heart block, severe
  10. Family medical history of the idiopathic sudden death
  11. Syncope like medical history
  12. QTcF> 450 ms
  13. Metastatic malignancy
  14. Pregnant or nursing women, women of childbearing age who have not achieved pregnancy test, women and men of reproductive age without effective contraception
  15. Impossible follow for psychological and/or geographical reasons.

Information from the National Library of Medicine

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


Locations
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France
Société Française d'Endoscopie Digestive (SFED)
Paris, France, 75006
Sponsors and Collaborators
Robert Benamouzig
Investigators
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Principal Investigator: Robert BENAMOUZIG Société Française d'Endoscopie Digestive

Publications:

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Responsible Party: Robert Benamouzig, Professor, Hospital Avicenne
ClinicalTrials.gov Identifier: NCT02622906    
Other Study ID Numbers: 2011-002579-40
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015
Keywords provided by Robert Benamouzig, Hospital Avicenne:
Gastrointestinal angiodysplasia
Pasireotide
Gastrointestinal bleeding
Additional relevant MeSH terms:
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Angiodysplasia
Vascular Diseases
Cardiovascular Diseases
Pasireotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs