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 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
NCT ID:
NCT00026468
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* One of the following diagnosis:
* Diagnosis of familial adenomatous polyposis
* Prior total or subtotal colectomy
* Attenuated adenomatous polyposis coli
* May have colon intact
* 10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater
PATIENT CHARACTERISTICS:
Age:
* 18 to 80
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Platelet count at least 100,000/mm\^3
* No active hematologic disease
Hepatic:
* AST and ALT less than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 1.5 times ULN
* No active hepatic disease
Renal:
* Creatinine less than 1.5 mg/dL
* No active renal disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active peptic ulcer disease
* No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival
* No prisoners or institutionalized patients
* No known allergy to sulindac or related compounds
* No active internal malignancy within the past 5 years
* No alcohol or drug abuse within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
Other:
* No prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months
* No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine)
* Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00026468
Study Brief:
Protocol Section:
NCT00026468