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

NCT ID: NCT00534677

Last Updated: 2007-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Portal Hypertension Cirrhosis Hematemesis Melena

Keywords

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Variceal bleed Cirrhosis Vasoactive agents Terlipressin Octreotide Safety & Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Terlipressin

Intervention Type DRUG

2 mg stat \& then 1 mg q6h iv and Placebo of Octreotide

B

Group Type ACTIVE_COMPARATOR

Octreotide

Intervention Type DRUG

Octreotide 50mcg/hr infusion \& a placebo of Terlipressin

Interventions

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Terlipressin

2 mg stat \& then 1 mg q6h iv and Placebo of Octreotide

Intervention Type DRUG

Octreotide

Octreotide 50mcg/hr infusion \& a placebo of Terlipressin

Intervention Type DRUG

Other Intervention Names

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Novapresin sandostatin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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The Aga Khan University

Principal Investigators

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Shahab Abid, FCPS, FACG

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Wasim Jafri, FRCP, FACG

Role: STUDY_DIRECTOR

Aga Khan University

Saeed S Hamid, FRCP, FACG

Role: STUDY_DIRECTOR

Aga Khan University

Salih Mohammad, FCPS; MACG

Role: STUDY_DIRECTOR

Aga Khan University

Locations

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The Aga Khan University Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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297-Med/ERC-04

Identifier Type: -

Identifier Source: org_study_id