Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

IL-10

About this trial

This is an interventional prevention trial for Bile Duct Diseases

Eligibility Criteria

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

Inclusion criteria: Adults weighing up to 125 kg who are undergoing ERCP for any of the following: Evaluate recurrent abdominal pain; Evaluate unexplained recurrent pancreatitis; Evaluate prior post-ERCP pancreatitis; Treatment of pancreatic disorders; Treatment of Common Bile Duct Stones (without jaundice) Exclusion criteria: Active (acute) pancreatitis; Chronic pancreatitis (moderate and severe cases); ERCP to perform a second procedure on biliary tract; Patients who previously had pancreatic sphincterotomy; Known or suspected pancreatic cancer or cancer of Papilla of Vater; Known or suspected other malignancy; History of, or current clotting or bleeding problems; Moderate and severe Anemia; Low platelet counts

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00040131

First Posted

June 20, 2002

Last Updated

October 30, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00040131

Brief Title

Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Study Start Date

January 2002 (undefined)

Primary Completion Date

December 2002 (Actual)

Study Completion Date

January 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine if a single dose of IL-10 compared to placebo is safe and effective in reducing the incidence of post-ERCP acute pancreatitis for subjects with increased risk.

6. Conditions and Keywords

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

Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases, Pancreatitis, Pancreatic Diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

316 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

IL-10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria: Adults weighing up to 125 kg who are undergoing ERCP for any of the following: Evaluate recurrent abdominal pain; Evaluate unexplained recurrent pancreatitis; Evaluate prior post-ERCP pancreatitis; Treatment of pancreatic disorders; Treatment of Common Bile Duct Stones (without jaundice) Exclusion criteria: Active (acute) pancreatitis; Chronic pancreatitis (moderate and severe cases); ERCP to perform a second procedure on biliary tract; Patients who previously had pancreatic sphincterotomy; Known or suspected pancreatic cancer or cancer of Papilla of Vater; Known or suspected other malignancy; History of, or current clotting or bleeding problems; Moderate and severe Anemia; Low platelet counts

Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial