Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-24 @ 12:06 PM
NCT ID:
NCT01146561
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female
* Written informed consent
* Diagnosis of chronic pancreatitis based on imaging studies
* Persistent abdominal pain due to chronic pancreatitis
* Qualifying pain score during the pre-treatment period
* Willing to comply with study visit schedule and study requirements including for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control
Exclusion Criteria:
* Pregnant women, lactating mothers, women suspected of being pregnant and women who wish to become pregnant during the course of the study
* Chronic pancreatitis as a complication of pancreatic cancer or acute pancreatic duct obstruction
* Pancreatic surgery, lithotripsy or endoscopist decompression within 3 months
* History of alcoholism (within 1 year of screening) or concurrent alcohol abuse
* History of cancer in the past years
* Significant cardiac disease within 6 months
* History, diagnosis or signs and symptoms of significant neurologic disease
* Disqualifying laboratory values including Hepatitis B or C, HIV and drug test
* Other medical condition that may interfere with study endpoints or safety of the patient as determined by the Investigator
* Known history of rheumatoid arthritis
* Avascular necrosis of the bone
* History of trauma to a major joint Evidence of osteoarthritis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01146561
Study Brief:
Protocol Section:
NCT01146561