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

This study has been completed.
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00534677
First received: September 24, 2007
Last updated: December 4, 2007
Last verified: September 2007
  Purpose

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 Intervention Phase
Portal Hypertension
Cirrhosis
Hematemesis
Melena
Drug: Terlipressin
Drug: Octreotide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Safety & Efficacy [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 320
Study Start Date: May 2004
Study Completion Date: July 2005
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr. Shahab Abid, The Aga Khan University
ClinicalTrials.gov Identifier: NCT00534677     History of Changes
Other Study ID Numbers: 297-Med/ERC-04
Study First Received: September 24, 2007
Last Updated: December 4, 2007
Health Authority: Pakistan: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014