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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014