The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed
This study has been completed.
Sponsor:
Aga Khan University
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00534677
First received: September 24, 2007
Last updated: December 4, 2007
Last verified: September 2007
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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:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
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
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:
|
Esophageal and Gastric Varices Hematemesis Hypertension Hypertension, Portal Liver Cirrhosis Fibrosis Melena Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Liver Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Vomiting |
Signs and Symptoms, Digestive Signs and Symptoms Vascular Diseases Cardiovascular Diseases Octreotide Terlipressin Lypressin Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Vasoconstrictor Agents Cardiovascular Agents Antihypertensive Agents |
ClinicalTrials.gov processed this record on June 18, 2013