Clinical trial NCT01674530: Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation
Official title: A,Randomized , Double-blind,Double -Dummy Placebo-controlled,Parallel -Group, Multicenter Study to Evaluate the Clinical Equivalence of Lubiprostone 24 mcg Capsules ( Dr. Reddy's Laboratories Ltd.) With AMITIZA® (Lubiprostone ) 24 mcg Capsules ( Sucampo Pharmaceuticals, Inc. ) in the Treatment of Chronic Idiopathic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Idiopathic Constipation
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2012-08-29
Enrollment: 909
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)

Eligibility criteria: Main Inclusion Criteria:

1. Patients who have signed the written informed consent form prior to entering the study.
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.

Main Exclusion Criteria:

1. Females who are pregnant, breast feeding, or planning a pregnancy during the proposed study period.
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.

Primary outcomes:
measure: Primary Analysis
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
measure: Safety Analysis
timeFrame: Day 8
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Mobile
country: United States
facility: Drug Research Group, LLC
state: Alabama
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Tucson
country: United States
facility: Adobe Clinical Research , LLC
state: Arizona
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: Tucson
country: United States
facility: SC Clinical Research, Inc
state: Arizona
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc,477 N. El Camino Real,Suite A100
state: California
city: Fresno
country: United States
facility: Advanced Medical Research Institute
state: California
city: Fresno
country: United States
facility: Research Center of Fresno
state: California
city: North Hollywood
country: United States
facility: Translational Research Group
state: California
city: Northridge
country: United States
facility: Staywell Research
state: California
city: Orange
country: United States
facility: Elias Research Associates
state: California
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: San Diego
country: United States
facility: Medical Center for CR
state: California
city: San Francisco
country: United States
facility: Shawn K Hassler
state: California
city: Upland
country: United States
facility: SC Clinical Research, Inc ,1060 E. Foothill Blvd, Suite 204
state: California
city: Vista
country: United States
facility: Progressive Clinical Research
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Denver
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Boynton Beach
country: United States
facility: Consultants of Clinical
state: Florida
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Elite Trials
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehabilitation and Research Center
state: Florida
city: Hialeah
country: United States
facility: Medical Research Unlimited, LLC
state: Florida
city: Jupiter
country: United States
facility: Health Awareness ,Inc
state: Florida
city: Lauderdale Lakes
country: United States
facility: Sunrise Medical Research
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Miami
country: United States
facility: Community Research Foundation , Inc.
state: Florida
city: Miami
country: United States
facility: Florida International Research
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services
state: Florida
city: Miami
country: United States
facility: South Medical Research Group , Inc
state: Florida
city: Naples
country: United States
facility: Pharma Research International, Inc
state: Florida
city: Naples
country: United States
facility: Pharma Research International, Inc
state: Florida
city: Orlando
country: United States
facility: Compass Research
state: Florida
city: Ormond
country: United States
facility: Ormond Medical Arts Pharmaceutical
state: Florida
city: Plant City
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research,LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Meridian Research
state: Florida
city: Tampa
country: United States
facility: Meridian Research
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
state: Florida
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Atlanta
country: United States
facility: Gastroenterology Consultants PC
state: Georgia
city: Marietta
country: United States
facility: Atlanta Gastroenterology Assoc
state: Georgia
city: Stockbridge
country: United States
facility: Advanced Digestive Care Center , PC
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Newton
country: United States
facility: Heartland Research Associates
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates
state: Kansas
city: Owensboro
country: United States
facility: Research Integrity
state: Kentucky
city: Metairie
country: United States
facility: East Jefferson Gastro
state: Louisiana
city: Boston
country: United States
facility: Boston Clinical Trials Inc
state: Massachusetts
city: Brockton
country: United States
facility: Beacon Clinical Research
state: Massachusetts
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Bayer Research
state: Michigan
city: Jackson
country: United States
facility: GI Associates and Endoscopy Center
state: Mississippi
city: Omaha
country: United States
facility: Quality Clinical Research, Inc
state: Nebraska
city: Elizabeth
country: United States
facility: Central Jersey Medical Research Center
state: New Jersey
city: Newark
country: United States
facility: University Hospital,150 Bergen Street,B-134 Pharmacy
state: New Jersey
city: Brooklyn
country: United States
facility: Hosc Inc.
state: New York
city: Hollis
country: United States
facility: NY Scientific,189-11 Jamaica Ave
state: New York
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research , Inc
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Lansdale
country: United States
facility: Detweiler Family Medicine and Associates, PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services, LLC
state: Pennsylvania
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Chattanooga
country: United States
facility: Clinsearch LLC
state: Tennessee
city: Jackson
country: United States
facility: HCCA-CRS
state: Tennessee
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Houston
country: United States
facility: Gastroenterology Consultants P.A
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Pasadena
country: United States
facility: Digestive Health Center
state: Texas
city: San Antonio
country: United States
facility: Paragon Research Center
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc
state: Texas
city: San Antonio
country: United States
facility: Sun Research
state: Texas
city: San Antonio
country: United States
facility: Texas Medical Research Associates , LLC
state: Texas
city: Sugarland
country: United States
facility: Breco Research
state: Texas
city: Sugarland
country: United States
facility: Pioneer Research Solutions , Inc
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center
state: Virginia
city: Lynchburg
country: United States
facility: BlueRidge Medical Research
state: Virginia
city: Newport news
country: United States
facility: Health Research of Hampton Roads
state: Virginia
Study officials:
affiliation: Dr. Reddy's Laboratories Limited
name: Ashis Patnaik, M.D
role: STUDY_DIRECTOR
affiliation: Dr. Reddy's Laboratories Limited
name: Shilpi Dhawan, M.D
role: STUDY_DIRECTOR
References: