Bile Duct DiseasesPhase 2NCT00040131
Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
A Phase 2 study testing IL-10 in people with Bile Duct Diseases and Biliary Tract Diseases, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases
- What is being tested?
- IL-10
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Jan 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- History of, or current clotting or bleeding problems;
- Moderate and severe Anemia;
- Low platelet counts
About this study
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.
- Conditions
- Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases, Pancreatitis, Pancreatic Diseases
- Being tested
- IL-10
- Medical subject headings
- Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases, Pancreatitis, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-10Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2002 (estimated)
- Study startJan 2002
- Primary completionDec 2002
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct DiseasesStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00040131
- Sponsor's protocol ID
- P02580
- Status last verified
- Oct 2015
- First submitted
- 20 Jun 2002
- Last updated
- 2 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of IL-10 (Tenovil TM) in the Prevention of Post-ERCP Acute Pancreatitis (Study P02580)(TERMINATED)
- ClinicalTrials.gov ID
- NCT00040131
- Acronym / sponsor ID
- P02580
- Conditions
- Bile Duct Diseases, Biliary Tract Diseases, Gallbladder Diseases, Pancreatitis, Pancreatic Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Dec 2002 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 21 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-10 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IL-10 in people with Bile Duct Diseases and Biliary Tract Diseases, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.