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| Sponsor: | Mayo Clinic |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00343629 |
Purpose
RATIONALE: Giving healthy volunteers sulindac capsules or sulindac tablets may help doctors learn which form of the drug may be more effective in preventing cancer.
PURPOSE: This randomized clinical trial is studying sulindac capsules to see how well they work compared with sulindac tablets in healthy volunteers.
| Condition | Intervention |
|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: sulindac Other: pharmacological study |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Prevention |
| Official Title: | Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations |
| Estimated Enrollment: | 28 |
| Study Start Date: | April 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 treatment arms.
Blood is collected periodically during treatment for pharmacokinetic studies.
After completion of study therapy, participants are followed at 7-10 days.
PROJECTED ACCRUAL: A total of 28 participants will be accrued for this study.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No uncontrolled concurrent illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
More than 6 months since prior regular use of (defined as a frequency of 7 consecutive days for > 3 weeks or > 21 days total) or other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX)-2 inhibitors including, but not limited to, the following:
More than 30 days since prior and no concurrent use of any of the following:
Angiotensin-converting enzymes (ACE) inhibitors
No concurrent regular aspirin use unless prescribed by a physician for prevention
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00343629 History of Changes |
| Other Study ID Numbers: | CDR0000473167, MAYO-03-1-BIO, MAYO-CPN0576, MAYO-05-004233 |
| Study First Received: | June 22, 2006 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific |
|
Sulindac Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |