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

Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices

Sponsors

Lead Sponsor: Aga Khan University

Source 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).

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.

Overall Status Completed
Start Date May 2004
Completion Date July 2005
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety & Efficacy 5 days
Enrollment 320
Condition
Intervention

Intervention Type: Drug

Intervention Name: Terlipressin

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

Arm Group Label: A

Other Name: Novapresin

Intervention Type: Drug

Intervention Name: Octreotide

Description: Octreotide 50mcg/hr infusion & a placebo of Terlipressin

Arm Group Label: B

Other Name: sandostatin

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility: The Aga Khan University Hospital
Location Countries

Pakistan

Verification Date

September 2007

Responsible Party

Name Title: Dr. Shahab Abid

Organization: The Aga Khan University

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: A

Type: Active Comparator

Label: B

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov