Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

NCT00343629 | Completed

• 4 other identifiers: CDR0000473167MAYO-03-1-BIOMAYO-CPN0576MAYO-05-004233
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

sulindac DRUG

pharmacological study OTHER

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Healthy volunteer PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Hemoglobin ≥ 12.0 g/dL (women) * Hemoglobin ≥ 13.5 g/dL (men) * WBC \> 3,000/mm³ * Platelet count \> 100,000/mm³ * Absolute neutrophil count \> 1,500/mm³ * Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * ALT ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30 mL/min * No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria * No condition that interferes with ingestion or absorption of oral medications * No cancer within the past 3 years except nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was previously treated \> 6 months ago * No uncontrolled concurrent illness including, but not limited to, the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Myocardial infarction in the past 6 months * Chronic renal disease * Chronic liver disease * Hypertension that is difficult to control * Psychiatric illness or social situations that would limit study compliance * No other significant clinical disorder or laboratory finding that would preclude study participation * No consumption of alcoholic or caffeinated beverages for ≥ 24 hours prior to study drug administration and until all blood samples have been drawn * Willing to provide required biologic specimens PRIOR CONCURRENT THERAPY: * More than 6 months since prior investigational agents * 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: * Ibuprofen * Ketoprofen * Naproxen * More than 6 weeks since prior oral corticosteroids * More than 30 days since prior and no concurrent use of any of the following: * Methotrexate * Corticosteroids * Warfarin * Ticlopidine * Clopidogrel * Low molecular weight heparins * Abciximab * Dipyridamole * Eptifibatide * Tirofiban * Lithium * Cyclosporine * Hydralazine * Angiotensin-converting enzymes (ACE) inhibitors * ACE-receptor antagonists allowed * Angiotensin-receptor blockers * Ginkgo * Ketorolac * Levofloxacin * Loop diuretics * Meadowsweet * Selective serotonin reuptake inhibitors * Danaparoid * No concurrent regular aspirin use unless prescribed by a physician for prevention * A maximum of one aspirin (81 mg/day) allowed * No concurrent herbal products (e.g., saw palmetto or Hypericum perforatum \[St. John's wort\])

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Sulindac

Intervention Hierarchy (Ancestors)

Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Paul J. Limburg, MD, MPH

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 23, 2006
• Study Start: April 1, 2006
• Study Completion: October 1, 2007
• Last Updated: April 28, 2015

Record last verified: 2006-12

Locations

US (1)