|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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 History of Changes |
| Health Authority: | Pakistan: Research Ethics Committee |
|
Variceal bleed Cirrhosis Vasoactive agents |
Terlipressin Octreotide Safety & Efficacy |
|
Liver Diseases Vomiting Coagulants Signs and Symptoms, Digestive Gastrointestinal Diseases Fibrosis Antineoplastic Agents Physiological Effects of Drugs Hematologic Agents Octreotide Liver Cirrhosis Hypertension, Portal Hemorrhage Signs and Symptoms Pathologic Processes |
Therapeutic Uses Terlipressin Vasoconstrictor Agents Cardiovascular Diseases Hematemesis Lysine Vasopressin Antineoplastic Agents, Hormonal Gastrointestinal Hemorrhage Vascular Diseases Gastrointestinal Agents Cardiovascular Agents Antihypertensive Agents Hemostatics Pharmacologic Actions Digestive System Diseases |
