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Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Irritable Bowel Syndrome

Intervention: Alosetron (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Summary

The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Clinical Details

Official title: A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 Mg QD, 1 Mg QD and 1 Mg BID of Alosetron in Female Subjects With Severe Diarrhea-Predominant IBS Who Have Failed Conventional Therapy

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.

Secondary outcome: Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).

- Failed conventional therapy.

- Willing to make daily calls on a touch-tone telephone.

Exclusion criteria:

- History of or current chronic or severe constipation.

- Bloody diarrhea, abdominal pain with rectal bleeding.

- Thrombophlebitis.

- Abnormal thyroid stimulating hormone (TSH) value.

- Alcohol and/or substance abuse within past two years.

- Pregnant or lactating.

- History/treatment of malignancy within past five years.

Locations and Contacts

GSK Clinical Trials Call Center, Birmingham, Alabama 35235, United States

GSK Clinical Trials Call Center, Tuscaloosa, Alabama 35406, United States

GSK Clinical Trials Call Center, Birmingham, Alabama 35235, United States

GSK Clinical Trials Call Center, Phoenix, Arizona 85006, United States

GSK Clinical Trials Call Center, Tucson, Arizona 85723, United States

GSK Clinical Trials Call Center, Fayetteville, Arkansas 72701, United States

GSK Clinical Trials Call Center, Newport Beach, California 92663, United States

GSK Clinical Trials Call Center, Redlands, California 92373, United States

GSK Clinical Trials Call Center, Santa Ana, California 92701, United States

GSK Clinical Trials Call Center, Rancho Cucamonga, California 91730, United States

GSK Clinical Trials Call Center, Garden Grove, California 92840, United States

GSK Clinical Trials Call Center, San Diego, California 92123, United States

GSK Clinical Trials Call Center, Santa Ana, California 92704, United States

GSK Clinical Trials Call Center, Yuba City, California 95991, United States

GSK Clinical Trials Call Center, Chula Vista, California 91910, United States

GSK Clinical Trials Call Center, Carmichael, California 95608, United States

GSK Clinical Trials Call Center, San Rafael, California 94901, United States

GSK Clinical Trials Call Center, Vista, California 92084, United States

GSK Clinical Trials Call Center, Fountain Valley, California 92708, United States

GSK Clinical Trials Call Center, San Diego, California 92103, United States

GSK Clinical Trials Call Center, Los Angeles, California 90045, United States

GSK Clinical Trials Call Center, Upland, California 91786, United States

GSK Clinical Trials Call Center, Lancaster, California 93534, United States

GSK Clinical Trials Call Center, Boulder, Colorado 80304, United States

GSK Clinical Trials Call Center, Englewood, Colorado 80113, United States

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GSK Clinical Trials Call Center, Colorado Springs, Colorado 80907, United States

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GSK Clinical Trials Call Center, Stamford, Connecticut 06905, United States

GSK Clinical Trials Call Center, Manchester, Connecticut 06040, United States

GSK Clinical Trials Call Center, Hialeah, Florida 33013, United States

GSK Clinical Trials Call Center, Naples, Florida 34102, United States

GSK Clinical Trials Call Center, Ocala, Florida 34471, United States

GSK Clinical Trials Call Center, Boynton Beach, Florida 33426, United States

GSK Clinical Trials Call Center, Lake Worth, Florida 33461, United States

GSK Clinical Trials Call Center, Fort Myers, Florida 33916, United States

GSK Clinical Trials Call Center, Miami, Florida 33186, United States

GSK Clinical Trials Call Center, Boynton Beach, Florida 33437, United States

GSK Clinical Trials Call Center, Miami Beach, Florida 33140, United States

GSK Clinical Trials Call Center, St. Petersburg, Florida 33702, United States

GSK Clinical Trials Call Center, Coral Gables, Florida 33134, United States

GSK Clinical Trials Call Center, Hollywood, Florida 33021, United States

GSK Clinical Trials Call Center, Longwood, Florida 32779, United States

GSK Clinical Trials Call Center, Boca Raton, Florida 33486, United States

GSK Clinical Trials Call Center, Zephyrhills, Florida 33540, United States

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GSK Clinical Trials Call Center, Miami, Florida 33156, United States

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GSK Clinical Trials Call Center, Tallahassee, Florida 32308, United States

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GSK Clinical Trials Call Center, Riverside, Illinois 60546, United States

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GSK Clinical Trials Call Center, South Bend, Indiana 46601, United States

GSK Clinical Trials Call Center, Indianapolis, Indiana 46254, United States

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GSK Clinical Trials Call Center, Davenport, Iowa 52807, United States

GSK Clinical Trials Call Center, Louisville, Kentucky 40291, United States

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GSK Clinical Trials Call Center, Madisonville, Kentucky 42431, United States

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GSK Clinical Trials Call Center, Attleboro, Massachusetts 02703, United States

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GSK Clinical Trials Call Center, Warren, Michigan 48089, United States

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GSK Clinical Trials Call Center, Ann Arbor, Michigan 48109, United States

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GSK Clinical Trials Call Center, Chaska, Minnesota 55318, United States

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GSK Clinical Trials Call Center, Jackson, Mississippi 39202, United States

GSK Clinical Trials Call Center, Wentzville, Missouri 63385, United States

GSK Clinical Trials Call Center, Kansas City, Missouri 64131, United States

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GSK Clinical Trials Call Center, Winston-Salem, North Carolina 27103, United States

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GSK Clinical Trials Call Center, Fayetteville, North Carolina 28304, United States

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GSK Clinical Trials Call Center, Cary, North Carolina 27511, United States

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GSK Clinical Trials Call Center, Chapel Hill, North Carolina 27599, United States

GSK Clinical Trials Call Center, Winston-Salem, North Carolina 27103, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27609, United States

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GSK Clinical Trials Call Center, Bismarck, North Dakota 58501, United States

GSK Clinical Trials Call Center, Lyndhurst, Ohio 44124, United States

GSK Clinical Trials Call Center, Cincinnati, Ohio 45220, United States

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GSK Clinical Trials Call Center, Dayton, Ohio 45440, United States

GSK Clinical Trials Call Center, Centerville, Ohio 45459, United States

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GSK Clinical Trials Call Center, Cincinnati, Ohio 45224, United States

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GSK Clinical Trials Call Center, Tulsa, Oklahoma 74136, United States

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GSK Clinical Trials Call Center, Medford, Oregon 97504, United States

GSK Clinical Trials Call Center, Wyomissing, Pennsylvania 19610, United States

GSK Clinical Trials Call Center, Newtown, Pennsylvania 18940, United States

GSK Clinical Trials Call Center, Fleetwood, Pennsylvania 19522, United States

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GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15212, United States

GSK Clinical Trials Call Center, Hershey, Pennsylvania 17033, United States

GSK Clinical Trials Call Center, East Providence, Rhode Island 02914, United States

GSK Clinical Trials Call Center, Simpsonville, South Carolina 29681, United States

GSK Clinical Trials Call Center, Columbia, South Carolina 29203, United States

GSK Clinical Trials Call Center, Greenville, South Carolina 29615, United States

GSK Clinical Trials Call Center, Chattanooga, Tennessee 37404, United States

GSK Clinical Trials Call Center, Kingsport, Tennessee 37660, United States

GSK Clinical Trials Call Center, Memphis, Tennessee 38120, United States

GSK Clinical Trials Call Center, Nashville, Tennessee 37203, United States

GSK Clinical Trials Call Center, Germantown, Tennessee 38138, United States

GSK Clinical Trials Call Center, Bristol, Tennessee 37620, United States

GSK Clinical Trials Call Center, Murfreesboro, Tennessee 37130, United States

GSK Clinical Trials Call Center, Houston, Texas 77002, United States

GSK Clinical Trials Call Center, Corsicana, Texas 75110, United States

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GSK Clinical Trials Call Center, Irving, Texas 75061, United States

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GSK Clinical Trials Call Center, Arlington, Texas 76012, United States

GSK Clinical Trials Call Center, Conroe, Texas 77384, United States

GSK Clinical Trials Call Center, Houston, Texas 77030, United States

GSK Clinical Trials Call Center, Dallas, Texas 75246, United States

GSK Clinical Trials Call Center, Houston, Texas 77030, United States

GSK Clinical Trials Call Center, Conroe, Texas 77384, United States

GSK Clinical Trials Call Center, Corpus Christi, Texas 78411, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78205, United States

GSK Clinical Trials Call Center, Bountiful, Utah 84010, United States

GSK Clinical Trials Call Center, West Jordan, Utah 84088, United States

GSK Clinical Trials Call Center, Ogden, Utah 84405, United States

GSK Clinical Trials Call Center, Chesapeake, Virginia 23320, United States

GSK Clinical Trials Call Center, Charlottesville, Virginia 22908, United States

GSK Clinical Trials Call Center, Alexandria, Virginia 22304, United States

GSK Clinical Trials Call Center, Charlottesville, Virginia 22911, United States

GSK Clinical Trials Call Center, Wenatchee, Washington 98801, United States

GSK Clinical Trials Call Center, Spokane, Washington 99208, United States

GSK Clinical Trials Call Center, Spokane, Washington 99207, United States

GSK Clinical Trials Call Center, Lacey, Washington 98516, United States

GSK Clinical Trials Call Center, Renton, Washington 98055, United States

GSK Clinical Trials Call Center, Walla Walla, Washington 99362, United States

GSK Clinical Trials Call Center, Yakima, Washington 98902, United States

GSK Clinical Trials Call Center, Milwaukee, Wisconsin 53207, United States

GSK Clinical Trials Call Center, Milwaukee, Wisconsin 53215, United States

GSK Clinical Trials Call Center, Milwaukee, Wisconsin 53209, United States

GSK Clinical Trials Call Center, Milwaukee, Wisconsin 53226, United States

GSK Clinical Trials Call Center, Milwaukee, Wisconsin 53212, United States

Additional Information

Starting date: June 2003
Last updated: March 7, 2006

Page last updated: June 20, 2008

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