Trial record 31 of 71 for:    pasireotide

Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure (ANGIOPAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Benamouzig, Hospital Avicenne
ClinicalTrials.gov Identifier:
NCT02622906
First received: December 3, 2015
Last updated: December 4, 2015
Last verified: December 2015
  Purpose

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 Intervention Phase
Angiodysplasia
Drug: Pasireotide
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Hospital Avicenne:

Primary Outcome Measures:
  • 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.


Enrollment: 24
Study Start Date: March 2012
Study Completion Date: October 2015
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02622906

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

Publications:

Responsible Party: Robert Benamouzig, Professor, Hospital Avicenne
ClinicalTrials.gov Identifier: NCT02622906     History of Changes
Other Study ID Numbers: 2011-002579-40 
Study First Received: December 3, 2015
Last Updated: December 4, 2015
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Hospital Avicenne:
Gastrointestinal angiodysplasia
Pasireotide
Gastrointestinal bleeding

Additional relevant MeSH terms:
Angiodysplasia
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2016