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

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT00547469

Run by

Dynogen Pharmaceuticals

People needed

360

Starts

2007-10-01

Last updated by the study team

2008-04-08

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States (enrolling)
• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States (enrolling)
• Mobile Medical Diagnostic — Mobile, Alabama, United States (enrolling)
• Pivotal Research Centers — Peoria, Arizona, United States (enrolling)
• Genova Clinical Research — Tucson, Arizona, United States (enrolling)
• Arkansas Gastroenterology — Sherwood, Arkansas, United States (enrolling)
• Impact Clinical Trials — Beverly Hills, California, United States (enrolling)
• Discovery Clinical Research — Encinitas, California, United States (enrolling)
• Family Medical Center — Foothill Ranch, California, United States (enrolling)
• Digestive and Liver Disease Specialist, A Medical Group, Inc. — Garden Grove, California, United States (enrolling)
• Prime Care Clinical Research, Inc. — Mission Vejo, California, United States (enrolling)
• California Research Foundation — San Diego, California, United States (enrolling)
• Medical Center for clinical research — San Diego, California, United States (enrolling)
• Westlake Medical Research — Westlake Village, California, United States (enrolling)
• Clinical Trial Center of Colorado, LLC — Castle Rock, Colorado, United States (enrolling)
• Clinical Trials Management of Boca Raton, Inc. — Boca Raton, Florida, United States (enrolling)
• Jupiter Research — Jupiter, Florida, United States (enrolling)
• AppleMed Research Inc. — Miami, Florida, United States (enrolling)
• Accord Clinical Research, LLC — Port Orange, Florida, United States (enrolling)
• Stedman Clinical Trials — Tampa, Florida, United States (enrolling)
• Mount Vernon Clinical Research — Atlanta, Georgia, United States (enrolling)
• Atlanta Gastroenterology Associates, LLC — Marietta, Georgia, United States (enrolling)
• North Georgia Clinical Research — Woodstock, Georgia, United States (enrolling)
• Rosemark WomenCare Specialists — Idaho Falls, Idaho, United States (enrolling)
• Alliance Clinical Trials — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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