The Safety & Efficacy of Terlipressin vs Octreotide for t... | NCT00534677

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

NCT00534677

Sponsor

Aga Khan University

Status

Completed

Last Update Posted

Dec 5, 2007Estimated

Enrollment

320Actual

Phase

Phase 4

Conditions

Portal Hypertension
Cirrhosis
Hematemesis
Melena

Interventions

Terlipressin
Octreotide

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Sep 24, 2007

First Submission Date that Met QC Criteria

Sep 24, 2007

First Posted Date

Sep 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2007

Last Update Posted Date

Dec 5, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator		Drug: Terlipressin
B	Active Comparator		Drug: Octreotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Terlipressin	Drug	2 mg stat & then 1 mg q6h iv and Placebo of Octreotide	A

Measure	Description	Time Frame
Safety & Efficacy		5 days

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shahab Abid, FCPS, FACG	Aga Khan University	Principal Investigator
Wasim Jafri, FRCP, FACG	Aga Khan University	Study Director
Saeed S Hamid, FRCP, FACG	Aga Khan University	Study Director
Salih Mohammad, FCPS; MACG	Aga Khan University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Aga Khan University Hospital		Karachi	Sindh	74800	Pakistan

Condition Browse Module

MeSH Terms

ID	Term
D006975	Hypertension, Portal
D005355	Fibrosis
D006396	Hematemesis
D008551	Melena

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077585	Terlipressin
D015282	Octreotide

Ancestor Terms

ID	Term
D008236	Lypressin
D014667	Vasopressins
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones

Browse Leaves

Not provided

Browse Branches

Not provided