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The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed

Sponsor
Aga Khan University (Other)
Overall Status
Completed
CT.gov ID
NCT00534677
Collaborator
(none)
320
Enrollment
1
Location
2
Arms
14
Duration (Months)
22.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH).

This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.

Study Design

Study Type:
Interventional
Actual Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices
Study Start Date :
May 1, 2004
Actual Study Completion Date :
Jul 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A

Drug: Terlipressin
2 mg stat & then 1 mg q6h iv and Placebo of Octreotide
Other Names:
  • Novapresin

    		•
    Active Comparator: B

    Drug: Octreotide
    Octreotide 50mcg/hr infusion & a placebo of Terlipressin
    Other Names:
  • sandostatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety & Efficacy [5 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age
    Exclusion Criteria:

    • Ulcerative esophagitis,

    • Mallory Weiss tear,

    • Bleeding gastric or duodenal ulcers,

    • Bleeding from gastric varices or portal hypertensive gastropathy and

    • Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Aga Khan University Hospital Karachi Sindh Pakistan 74800

    Sponsors and Collaborators

    • Aga Khan University

    Investigators

    • Principal Investigator: Shahab Abid, FCPS, FACG, The Aga Khan University
    • Study Director: Wasim Jafri, FRCP, FACG, The Aga Khan University
    • Study Director: Saeed S Hamid, FRCP, FACG, The Aga Khan University
    • Study Director: Salih Mohammad, FCPS; MACG, The Aga Khan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00534677
    Other Study ID Numbers:
    • 297-Med/ERC-04
    First Posted:
    Sep 26, 2007
    Last Update Posted:
    Dec 5, 2007
    Last Verified:
    Sep 1, 2007
    Keywords provided by , ,
    Variceal bleed
    Cirrhosis
    Vasoactive agents
    Terlipressin
    Octreotide
    Safety & Efficacy
    Additional relevant MeSH terms:
    Hypertension, Portal
    Hematemesis
    Fibrosis
    Octreotide
    Terlipressin

    Study Results

    No Results Posted as of Dec 5, 2007