Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00343629
First received: June 22, 2006
Last updated: May 1, 2013
Last verified: December 2006
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 28
Study Start Date: April 2006
Study Completion Date: October 2007
Detailed Description:

OBJECTIVES:

Primary

  • Compare the systemic exposure of sulindac tablets vs sulindac capsules in healthy volunteers.

Secondary

  • Compare the terminal half-life and time of peak drug concentration of sulindac tablets vs sulindac capsules.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 treatment arms.

  • Arm I: Participants receive one sulindac capsule followed 7-10 days later by one sulindac tablet.
  • Arm II: Participants receive one sulindac tablet followed 7-10 days later by one sulindac capsule.

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
Criteria

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])
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343629

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Paul J. Limburg, MD, MPH Mayo Clinic
  More Information

Additional Information:
No publications provided

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: May 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on April 20, 2014