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

NCT00534677 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2007-12-05

No results posted yet for this study

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).

Conditions

  • Portal Hypertension
  • Cirrhosis
  • Hematemesis
  • Melena

Interventions

DRUG

Terlipressin

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

DRUG

Octreotide

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

Sponsors & Collaborators

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Shahab Abid, FCPS, FACG · Aga Khan University

  • Wasim Jafri, FRCP, FACG · Aga Khan University

  • Saeed S Hamid, FRCP, FACG · Aga Khan University

  • Salih Mohammad, FCPS; MACG · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Completion
2005-07-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534677 on ClinicalTrials.gov