Back to results

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

Primary Purpose

Portal Hypertension, Cirrhosis, Hematemesis

Status

Completed

Phase

Phase 4

Locations

Pakistan

Study Type

Interventional

Intervention

Terlipressin

Octreotide

About this trial

This is an interventional treatment trial for Portal Hypertension focused on measuring Variceal bleed, Cirrhosis, Vasoactive agents, Terlipressin, Octreotide, Safety & Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Aga Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Safety & Efficacy

Secondary Outcome Measures

Full Information

NCT ID

NCT00534677

First Posted

September 24, 2007

Last Updated

December 4, 2007

Sponsor

Aga Khan University

1. Study Identification

Unique Protocol Identification Number

NCT00534677

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Aga Khan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Portal Hypertension, Cirrhosis, Hematemesis, Melena

Keywords

Variceal bleed, Cirrhosis, Vasoactive agents, Terlipressin, Octreotide, Safety & Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

320 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Terlipressin

Other Intervention Name(s)

Novapresin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Octreotide

Other Intervention Name(s)

sandostatin

Intervention Description

Octreotide 50mcg/hr infusion & a placebo of Terlipressin

Primary Outcome Measure Information:

Title

Safety & Efficacy

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shahab Abid, FCPS, FACG

Organizational Affiliation

The Aga Khan University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wasim Jafri, FRCP, FACG

Organizational Affiliation

The Aga Khan University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Saeed S Hamid, FRCP, FACG

Organizational Affiliation

The Aga Khan University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Salih Mohammad, FCPS; MACG

Organizational Affiliation

The Aga Khan University

Official's Role

Study Director

Facility Information:

Facility Name

The Aga Khan University Hospital

City

Karachi

State/Province

Sindh

ZIP/Postal Code

74800

Country

Pakistan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs