Clinical Trial 32730

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El Paso, TX 79905


Study Summary:

Efficacy of Linaclotide in Type II Diabetics with Chronic Constipation:
A Randomized, Double- Blind, Placebo- Controlled, and Cross- Over Trail

Purpose of this study

The main purpose of this study is to find out if 4 weeks of treatment with Linaclotide (study drug) will help your symptoms of chronic constipation as compared with 4 weeks duration with a placebo (non-active drug) in patients diagnosed with Type II Diabetes.

Inclusion criteria
  • Ages 18-70 men and women
  • Type II diabetics
  • At least 6 month history of constipation

  • Exclusion criteria
    • Pregnant/ lactating
    • Diarrhea
    • Use of laxatives 3 days immediately prior to randomization
    • Use of illegal drugs
    • History or current diagnosis of diverticulitis and sever hemorrhoids
    • History of gastric resections, partial colon resection, history of rectocele
    • Existence of any major medical condition such as malignancy, severe renal and liver disease.

    Study Duration- totally up to 3 months
    • Up to 3 weeks of screening prior to randomization
    • 8 weeks of treatment starting at randomization
    • 2 weeks of washout period, where not medication is taken between treatment phases

    Benefits
    It is anticipated that by using the study drug it may benefit diabetic patients with chronic constipation. Many other patients who suffer with similar infrequent bowel movements as a complication of their diabetes could be helped with Linaclotide treatment also.

    There is a possible compensation for your time and travel.


    Study is Available At:

    Texas Tech University Health Sciences Center
    Department of Internal Medicine

    5001 El Paso Drive
    El Paso, TX 79905
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    If you or someone you care for is interested in participating in this clinical trial and lives within 50 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

    Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.