Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation
NCT ID: NCT01674530
Last Updated: 2014-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
909 participants
INTERVENTIONAL
2012-10-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lubiprostone
Manufactured by Dr Reddy's Laboratories Ltd( 24 mcg administered for 7 days )
Lubiprostone
24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA
AMITIZA®
Manufactured by Sucampo Pharmaceuticals(24 mcg administered for 7 days)
Lubiprostone
24 mcg Capsules with placebo of Lubiprostone ( Manufactured by Dr Reddy's Laboratories Ltd)
Placebo
Manufactured by Dr Reddy's Laboratories Ltd ( 24 mcg adminstered for 7 days )
Placebo
24 mcg capsules of both experimental Lubiprostone and AMITIZA
Interventions
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Lubiprostone
24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA
Lubiprostone
24 mcg Capsules with placebo of Lubiprostone ( Manufactured by Dr Reddy's Laboratories Ltd)
Placebo
24 mcg capsules of both experimental Lubiprostone and AMITIZA
Eligibility Criteria
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Inclusion Criteria
2. Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of CIC defined as, on average, \< 3 SBMs per week and confirmed by daily diary during the two week baseline/washout period. An SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use.
3. Patients with body mass index between 18 and 35kg/m2 (both inclusive)
4. Have one or more of the following symptoms related to BMs for at least 6 months before the baseline visit and confirmed by daily diary during the 2 weeks baseline/washout period:
i. very hard (little balls) and/or hard stools for at least 25% of the bowel movements ii. sensation of incomplete evacuation following at least 25% of the bowel movements iii. straining at defecation at least a quarter of the time
5. Women of child-bearing potential should have a negative serum pregnancy test prior to beginning therapy and agree to use effective contraceptive methods (at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal IUDs, sexual abstinence or vasectomy of the partner) during the study.
6. For patients aged \< 50 years, documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within the five years prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.
7. For patients aged ≥ 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within one year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.
Exclusion Criteria
2. Patients of any age with evidence of weight loss, anemia, or rectal bleeding and without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed during the 6 months prior to dosing.
3. Patients who have documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.
4. Patients with known or suspected organic disorders of the large or small bowel (e.g., inflammatory bowel disease, ulcerative colitis, Crohn's Disease) or constipation secondary to a documented cause (e.g., surgery, bowel resection) or acute hernia or with neurologic diseases or other diseases that cause motility problems for example Parkinson's disease and spinal cord injury, etc.
5. Patients with a history of bowel resection.
6. Patients who are regularly using medications, which are known to cause constipation (anticholinergics, narcotics, calcium channel blockers, tricyclic antidepressants, colchicine, iron supplements, magnesium supplements).
7. Patients who are hospitalized for any gastrointestinal or abdominal surgical procedure during the three months prior to dosing.
8. Patients with clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities (if laboratory values exceed 2X Upper Limit of Normal the approval of medical monitor should be taken into consideration before randomizing the patient).
9. Use of systemic antibiotics within four weeks prior to baseline.
10. Any current or planned significant change in diet during the study.
11. Participation in a study with any investigational medication within the past 30 days before screening for this study or previous participation in this study.
18 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Dr. Reddy's Laboratories Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Ashis Patnaik, M.D
Role: STUDY_DIRECTOR
Dr. Reddy's Laboratories Limited
Shilpi Dhawan, M.D
Role: STUDY_DIRECTOR
Dr. Reddy's Laboratories Limited
Locations
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Radiant Research
Birmingham, Alabama, United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Clinical Research Associates
Huntsville, Alabama, United States
Drug Research Group, LLC
Mobile, Alabama, United States
Radiant Research
Scottsdale, Arizona, United States
Adobe Clinical Research , LLC
Tucson, Arizona, United States
Visions Clinical Research
Tucson, Arizona, United States
SC Clinical Research, Inc
Tucson, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Anaheim Clinical Trials
Anaheim, California, United States
Diagnamics Inc,477 N. El Camino Real,Suite A100
Encinitas, California, United States
Advanced Medical Research Institute
Fresno, California, United States
Research Center of Fresno
Fresno, California, United States
Translational Research Group
North Hollywood, California, United States
Staywell Research
Northridge, California, United States
Elias Research Associates
Orange, California, United States
Benchmark Research
Sacramento, California, United States
Medical Center for CR
San Diego, California, United States
Shawn K Hassler
San Francisco, California, United States
SC Clinical Research, Inc ,1060 E. Foothill Blvd, Suite 204
Upland, California, United States
Progressive Clinical Research
Vista, California, United States
Horizons Clinical Research Center
Denver, Colorado, United States
Radiant Research
Denver, Colorado, United States
Lynn Institute of Denver
Denver, Colorado, United States
Consultants of Clinical
Boynton Beach, Florida, United States
PAB Clinical Research
Brandon, Florida, United States
Elite Trials
Clearwater, Florida, United States
Health Care Family Rehabilitation and Research Center
Hialeah, Florida, United States
Medical Research Unlimited, LLC
Hialeah, Florida, United States
Health Awareness ,Inc
Jupiter, Florida, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
San Marcus Research Clinic
Miami, Florida, United States
Pharmax Research Clinic
Miami, Florida, United States
Community Research Foundation , Inc.
Miami, Florida, United States
Florida International Research
Miami, Florida, United States
Columbus Clinical Services
Miami, Florida, United States
South Medical Research Group , Inc
Miami, Florida, United States
Pharma Research International, Inc
Naples, Florida, United States
Pharma Research International, Inc
Naples, Florida, United States
Compass Research
Orlando, Florida, United States
Ormond Medical Arts Pharmaceutical
Ormond Beach, Florida, United States
Clinical Research of Central Florida
Plant City, Florida, United States
Accord Clinical Research,LLC
Port Orange, Florida, United States
Meridian Research
St. Petersburg, Florida, United States
Meridian Research
Tampa, Florida, United States
Clinical Research of Central Florida
Winter Haven, Florida, United States
Mount Vernon Clinical Research
Atlanta, Georgia, United States
Gastroenterology Consultants PC
Atlanta, Georgia, United States
Atlanta Gastroenterology Assoc
Marietta, Georgia, United States
Advanced Digestive Care Center , PC
Stockbridge, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Heartland Research Associates
Newton, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
Research Integrity
Owensboro, Kentucky, United States
East Jefferson Gastro
Metairie, Louisiana, United States
Boston Clinical Trials Inc
Boston, Massachusetts, United States
Beacon Clinical Research
Brockton, Massachusetts, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Clinical Research Institute
Chesterfield, Michigan, United States
Bayer Research
Kalamazoo, Michigan, United States
GI Associates and Endoscopy Center
Jackson, Mississippi, United States
Quality Clinical Research, Inc
Omaha, Nebraska, United States
Central Jersey Medical Research Center
Elizabeth, New Jersey, United States
University Hospital,150 Bergen Street,B-134 Pharmacy
Newark, New Jersey, United States
Hosc Inc.
Brooklyn, New York, United States
NY Scientific,189-11 Jamaica Ave
Hollis, New York, United States
Peters Medical Research
High Point, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Valley Medical Research
Centerville, Ohio, United States
Rapid Medical Research , Inc
Cleveland, Ohio, United States
Radiant Research
Columbus, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
Detweiler Family Medicine and Associates, PC
Lansdale, Pennsylvania, United States
Clinical Trials Research Services, LLC
Pittsburgh, Pennsylvania, United States
Radiant Research
Greer, South Carolina, United States
Clinsearch LLC
Chattanooga, Tennessee, United States
HCCA-CRS
Jackson, Tennessee, United States
KRK Medical Research
Dallas, Texas, United States
Gastroenterology Consultants P.A
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Digestive Health Center
Pasadena, Texas, United States
Paragon Research Center
San Antonio, Texas, United States
Quality Research, Inc
San Antonio, Texas, United States
Sun Research
San Antonio, Texas, United States
Texas Medical Research Associates , LLC
San Antonio, Texas, United States
Breco Research
Sugarland, Texas, United States
Pioneer Research Solutions , Inc
Sugarland, Texas, United States
Charlottesville Medical Research Center
Charlottesville, Virginia, United States
BlueRidge Medical Research
Lynchburg, Virginia, United States
Health Research of Hampton Roads
Newport News, Virginia, United States
Countries
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Other Identifiers
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DRL-USG01-L/2012
Identifier Type: -
Identifier Source: org_study_id
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