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

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ClinicalTrials.gov Identifier: NCT00534677
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Aga Khan University

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
Portal Hypertension Cirrhosis Hematemesis Melena Drug: Terlipressin Drug: Octreotide 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 Type : Interventional  (Clinical Trial)
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 2004
Actual Study Completion Date : July 2005


Arm Intervention/treatment
Active Comparator: A Drug: Terlipressin
2 mg stat & then 1 mg q6h iv and Placebo of Octreotide
Other Name: Novapresin
Active Comparator: B Drug: Octreotide
Octreotide 50mcg/hr infusion & a placebo of Terlipressin
Other Name: sandostatin



Primary Outcome Measures :
  1. Safety & Efficacy [ Time Frame: 5 days ]


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

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.

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): NCT00534677


Locations
Pakistan
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

Responsible Party: Dr. Shahab Abid, The Aga Khan University
ClinicalTrials.gov Identifier: NCT00534677     History of Changes
Other Study ID Numbers: 297-Med/ERC-04
First Posted: September 26, 2007    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: September 2007

Keywords provided by Aga Khan University:
Variceal bleed
Cirrhosis
Vasoactive agents
Terlipressin
Octreotide
Safety & Efficacy

Additional relevant MeSH terms:
Fibrosis
Hypertension, Portal
Hematemesis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Gastrointestinal Hemorrhage
Gastrointestinal Diseases
Hemorrhage
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Octreotide
Terlipressin
Lypressin
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antihypertensive Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs