Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Drug: Placebo
- Registration Number
- NCT01674530
- Lead Sponsor
- Dr. Reddy's Laboratories Limited
- Brief Summary
The objective of this study is to evaluate the clinical equivalence and safety of the test formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd compared to the marketed formulation AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed Chronic Idiopathic Constipation
- Detailed Description
Constipation is a common gastrointestinal problem estimated to effect 2-27 % of the population in United States . It is found more commonly in women and elderly . The prevelance of constipation and growing demand for treatment dictate the need for safe and effective treatment options . Lubiprostone is the first chloride channel activator approved by FDA for long term treatment of chronic idiopathic constipation in adult men and women . To provide a generic medicine to the U.S population Dr Reddy's Laboratories intends to conduct this study to evaluate that the Lubiprostone manufactured by it is equally effective and safe as marketed AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 909
-
Patients who have signed the written informed consent form prior to entering the study.
-
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.
-
Patients with body mass index between 18 and 35kg/m2 (both inclusive)
-
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
-
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.
-
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.
-
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.
Main
- Females who are pregnant, breast feeding, or planning a pregnancy during the proposed study period.
- 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.
- Patients who have documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.
- 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.
- Patients with a history of bowel resection.
- Patients who are regularly using medications, which are known to cause constipation (anticholinergics, narcotics, calcium channel blockers, tricyclic antidepressants, colchicine, iron supplements, magnesium supplements).
- Patients who are hospitalized for any gastrointestinal or abdominal surgical procedure during the three months prior to dosing.
- 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).
- Use of systemic antibiotics within four weeks prior to baseline.
- Any current or planned significant change in diet during the study.
- Participation in a study with any investigational medication within the past 30 days before screening for this study or previous participation in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lubiprostone Lubiprostone Manufactured by Dr Reddy's Laboratories Ltd( 24 mcg administered for 7 days ) AMITIZA® Lubiprostone Manufactured by Sucampo Pharmaceuticals(24 mcg administered for 7 days) Placebo Placebo Manufactured by Dr Reddy's Laboratories Ltd ( 24 mcg adminstered for 7 days )
- Primary Outcome Measures
Name Time Method Primary Analysis Day 8 Clinical equivalence of the Test and Reference treatments and the superiority of each active treatment over the Placebo in the change from baseline in mean number of SBM's during the 7 day treatment period of the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (85)
Research Integrity
🇺🇸Owensboro, Kentucky, United States
Bayer Research
🇺🇸Kalamazoo, Michigan, United States
Mount Vernon Clinical Research
🇺🇸Atlanta, Georgia, United States
Gastroenterology Consultants PC
🇺🇸Atlanta, Georgia, United States
Rapid Medical Research , Inc
🇺🇸Cleveland, Ohio, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
Consultants of Clinical
🇺🇸Boynton Beach, Florida, United States
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Elias Research Associates
🇺🇸Orange, California, United States
Research Center of Fresno
🇺🇸Fresno, California, United States
Drug Research Group, LLC
🇺🇸Mobile, Alabama, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Diagnamics Inc,477 N. El Camino Real,Suite A100
🇺🇸Encinitas, California, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Advanced Medical Research Institute
🇺🇸Fresno, California, United States
Breco Research
🇺🇸Sugarland, Texas, United States
KRK Medical Research
🇺🇸Dallas, Texas, United States
Hosc Inc.
🇺🇸Brooklyn, New York, United States
Columbus Clinical Services
🇺🇸Miami, Florida, United States
Pharmax Research Clinic
🇺🇸Miami, Florida, United States
Florida International Research
🇺🇸Miami, Florida, United States
South Medical Research Group , Inc
🇺🇸Miami, Florida, United States
Boston Clinical Trials Inc
🇺🇸Boston, Massachusetts, United States
Gastroenterology Consultants P.A
🇺🇸Houston, Texas, United States
Clinical Trial Network
🇺🇸Houston, Texas, United States
Paragon Research Center
🇺🇸San Antonio, Texas, United States
Sun Research
🇺🇸San Antonio, Texas, United States
Texas Medical Research Associates , LLC
🇺🇸San Antonio, Texas, United States
Quality Research, Inc
🇺🇸San Antonio, Texas, United States
Medical Center for CR
🇺🇸San Diego, California, United States
Shawn K Hassler
🇺🇸San Francisco, California, United States
Heartland Research Associates
🇺🇸Wichita, Kansas, United States
Horizons Clinical Research Center
🇺🇸Denver, Colorado, United States
Lynn Institute of Denver
🇺🇸Denver, Colorado, United States
Quality Clinical Research, Inc
🇺🇸Omaha, Nebraska, United States
Great Lakes Gastroenterology
🇺🇸Mentor, Ohio, United States
Charlottesville Medical Research Center
🇺🇸Charlottesville, Virginia, United States
Pioneer Research Solutions , Inc
🇺🇸Sugarland, Texas, United States
BlueRidge Medical Research
🇺🇸Lynchburg, Virginia, United States
Adobe Clinical Research , LLC
🇺🇸Tucson, Arizona, United States
Visions Clinical Research
🇺🇸Tucson, Arizona, United States
Staywell Research
🇺🇸Northridge, California, United States
SC Clinical Research, Inc ,1060 E. Foothill Blvd, Suite 204
🇺🇸Upland, California, United States
Elite Trials
🇺🇸Clearwater, Florida, United States
Medical Research Unlimited, LLC
🇺🇸Hialeah, Florida, United States
San Marcus Research Clinic
🇺🇸Miami, Florida, United States
Community Research Foundation , Inc.
🇺🇸Miami, Florida, United States
Pharma Research International, Inc
🇺🇸Naples, Florida, United States
Ormond Medical Arts Pharmaceutical
🇺🇸Ormond, Florida, United States
Clinical Research of Central Florida
🇺🇸Winter Haven, Florida, United States
Accord Clinical Research,LLC
🇺🇸Port Orange, Florida, United States
Advanced Digestive Care Center , PC
🇺🇸Stockbridge, Georgia, 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
GI Associates and Endoscopy Center
🇺🇸Jackson, Mississippi, United States
Central Jersey Medical Research Center
🇺🇸Elizabeth, New Jersey, United States
NY Scientific,189-11 Jamaica Ave
🇺🇸Hollis, New York, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Valley Medical Research
🇺🇸Centerville, Ohio, United States
Detweiler Family Medicine and Associates, PC
🇺🇸Lansdale, Pennsylvania, United States
Health Research of Hampton Roads
🇺🇸Newport news, Virginia, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
Sunrise Medical Research
🇺🇸Lauderdale Lakes, Florida, United States
Translational Research Group
🇺🇸North Hollywood, California, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Progressive Clinical Research
🇺🇸Vista, California, United States
Health Awareness ,Inc
🇺🇸Jupiter, Florida, United States
Health Care Family Rehabilitation and Research Center
🇺🇸Hialeah, Florida, United States
Atlanta Gastroenterology Assoc
🇺🇸Marietta, Georgia, United States
Digestive Health Center
🇺🇸Pasadena, Texas, United States
SC Clinical Research, Inc
🇺🇸Tucson, Arizona, United States
HCCA-CRS
🇺🇸Jackson, Tennessee, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
East Jefferson Gastro
🇺🇸Metairie, Louisiana, United States
University Hospital,150 Bergen Street,B-134 Pharmacy
🇺🇸Newark, New Jersey, United States
Clinsearch LLC
🇺🇸Chattanooga, Tennessee, United States
Compass Research
🇺🇸Orlando, Florida, United States
Benchmark Research
🇺🇸Sacramento, California, United States
Meridian Research
🇺🇸Tampa, Florida, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Radiant Research
🇺🇸Greer, South Carolina, United States