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| Sponsored by: |
Aga Khan University |
|---|---|
| Information provided by: | Aga Khan University |
| ClinicalTrials.gov Identifier: | NCT00534677 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy And Safety Of Terlipressin Vs Octreotide As Adjuvant Therapy In Bleeding Esophageal Varices |
| Enrollment: | 320 |
| Study Start Date: | May 2004 |
| Study Completion Date: | July 2005 |
| Arms | Assigned Interventions |
|---|---|
| A: Active Comparator |
Drug: Terlipressin
2 mg stat & then 1 mg q6h iv and Placebo of Octreotide
|
| B: Active Comparator |
Drug: Octreotide
Octreotide 50mcg/hr infusion & a placebo of Terlipressin
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Pakistan, Sindh | |
| The Aga Khan University Hospital | |
| Karachi, Sindh, Pakistan, 74800 | |
| 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
| Responsible Party: | The Aga Khan University ( Dr. Shahab Abid ) |
| Study ID Numbers: | 297-Med/ERC-04 |
| Study First Received: | September 24, 2007 |
| Last Updated: | December 4, 2007 |
| ClinicalTrials.gov Identifier: | NCT00534677 |
| Health Authority: | Pakistan: Research Ethics Committee |
|
Variceal bleed Cirrhosis Vasoactive agents |
Terlipressin Octreotide Safety & Efficacy |
|
Lysine Vasopressin Liver Diseases Vomiting Esophageal disorder Signs and Symptoms, Digestive Fibrosis Gastrointestinal Diseases Vascular Diseases Gastrointestinal Hemorrhage Octreotide Liver Cirrhosis Hypertension, Portal |
Hemorrhage Portal hypertension Arginine Vasopressin Esophageal varices Signs and Symptoms Digestive System Diseases Varicose Veins Terlipressin Vasopressins Esophageal Diseases Hematemesis Hypertension |
|
Antineoplastic Agents, Hormonal Coagulants Antineoplastic Agents Physiological Effects of Drugs Hematologic Agents Gastrointestinal Agents Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Hemostatics Pathologic Processes Natriuretic Agents Therapeutic Uses Vasoconstrictor Agents Cardiovascular Diseases Antidiuretic Agents |
