NCT00040131

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2002

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2002

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

11 months

First QC Date

June 20, 2002

Last Update Submit

October 30, 2015

Conditions

Bile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesPancreatitisPancreatic Diseases

Interventions

IL-10DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesPancreatitisPancreatic Diseases

Interventions

Interleukin-10

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2002

First Posted

June 21, 2002

Study Start

January 1, 2002

Primary Completion

December 1, 2002

Study Completion

January 1, 2003

Last Updated

November 2, 2015

Record last verified: 2015-10