A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females



Status:Recruiting
Conditions:Constipation, Irritable Bowel Syndrome (IBS)
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:4/2/2016
Start Date:October 2007

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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Effectiveness of DDP733 in Female Patients With Irritable Bowel Syndrome With Constipation

This study will evaluate the safety and effectiveness of the investigational drug DDP733 in
treating female patients with IBS-c. A placebo control will be utilized.


Inclusion Criteria:

- Female from 18 to 65 years of age, inclusive

- Patient experiences recurrent abdominal pain or discomfort at least 3 days per month
for the last 3 months with symptom onset at least 6 months prior to diagnosis. The
patient's symptoms must be associated with 1 or more of the following:

- Improvement with defecation

- Onset associated with a change in frequency of stool

- Onset associated with a change in form (appearance) of stool

- Negative serum and urine pregnancy tests

- Completion of at least six days of daily diary assessments using a phone-in
information system prior to randomization

Exclusion Criteria:

- Serious underlying diseases, including psychiatric disorders

- Current history of conditions affecting bowel transit

- Recent history of biochemical or structural abnormalities of the gastrointestinal
tract, gastrointestinal surgery, or gastrointestinal infection

- Clinically significant abnormal examination findings or laboratory tests

- Inability to stop taking certain medications, or a planned change in medications
(including herbal remedies) which could interfere with study assessments

- Use of drugs and or ethanol which may interfere with compliance of study procedures
or influence study outcome

- Presence of a medical condition which could interfere with the interpretation of
study data

- Significant use of nicotine or caffeine
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Paw Paw, Michigan 49079
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3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
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5458 Town Center Rd # 19
Boca Raton, Florida 33486
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303 Williams Ave
Huntsville, Alabama 35801
256-533-6603
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875 Military Trl # 210
Jupiter, Florida 33458
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135 W. Ravine Road
Kingsport, Tennessee 37660
423-230-3154
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6850 Coral Way # 409
Miami, Florida 33155
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401 Roxbury Road
Rockford, Illinois 61107
815-397-7340
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3212 Cove Bend Drive
Tampa, Florida 33613
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6261 N. La Cholla Blvd
Tucson, Arizona 85741
520-219-6394
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Atlanta, Georgia 30328
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Beverly Hills, California 90211
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Birmingham, Alabama 35215
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Boston, Massachusetts 02135
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Brooklyn, New York 11214
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Castle Rock, Colorado 80108
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Chapel Hill, North Carolina 27514
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Chattanooga, Tennessee 37403
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Cleveland, Ohio 44122
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ELkhart, Indiana 46514
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Evansville, Indiana 47714
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Henderson, Nevada 89014
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High Point, North Carolina 27262
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Idaho Falls, Idaho 83404
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Jackson, Mississippi 39202
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Jackson, Tennessee 38305
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Jackson, Tennessee 38301
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Longview, Texas 75605
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Mexico City, Missouri 65265
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Mission Vejo, California 92691
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Mobile, Alabama 36617
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Ogden, Utah 84405
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Pittsburgh, Pennsylvania 15206
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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San Diego, California 92108
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Westlake Village, California 91361
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