Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure

NCT02622906 | Completed Phase 2

• 1 other identifier: 2011-002579-40
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Angiodysplasia

Keywords

Gastrointestinal angiodysplasia; Pasireotide; Gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

• number of red blood cells transfused

  number of red blood cells transfused at 6 months in patients treated with pasireotide or placebo.

  at 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1 injection per month during 6 months of the placebo product

Drug: Placebo

Pasireotide

ACTIVE COMPARATOR

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

Drug: Pasireotide

Interventions

Pasireotide DRUG

60 mg per month of the Pasireotide during 6 months

Pasireotide

Placebo DRUG

Vehicule injection per month during 6 months

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Angiodysplasia of the stomach, small intestine or colon confirmed by endoscopy.
• Failed endoscopic therapy or cons-indication for endoscopic treatment.
• Patient affiliated to a social security insurance.
• Age \> 18 years.
• Consent signed by the patient.

You may not qualify if:

• Symptomatic cholelithiasis
• Rendu-Osler disease
• Uncontrolled diabetes (HbA1c \> 8%)
• Breaking of the esophageal varicose veins bleeding older than six months.
• Patients treated with anti vitamin K at baseline and during the study.
• Patients with (AST, ALT\> 2 ULN) and / or total bilirubin \> 1.5 ULN.
• TP \< 50%, platelets \<75 000/mm3, aPTT\> 1.5 times the control
• 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
• Family medical history of the idiopathic sudden death
• Syncope like medical history
• QTcF\> 450 ms
• Metastatic malignancy
• Pregnant or nursing women, women of childbearing age who have not achieved pregnancy test, women and men of reproductive age without effective contraception
• Impossible follow for psychological and/or geographical reasons.

Sponsors & Collaborators

• Robert Benamouzig: lead

Study Sites (1)

Société Française d'Endoscopie Digestive (SFED)

Paris, 75006, France

Location

Related Publications (18)

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  PMID: 17990111 BACKGROUND

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MeSH Terms

Conditions

Angiodysplasia; Gastrointestinal Hemorrhage

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert BENAMOUZIG

  Société Française d'Endoscopie Digestive

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 7, 2015
• Study Start: March 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2015
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

FR (1)