Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation

Chronic Idiopathic Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674530
• Other study ID #: DRL-USG01-L/2012
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2012
• Last updated: April 2, 2014
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2012
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 909
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited	Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Analysis	The type , frequency and severity of adverse events across the treatment groups will be analyzed at the end of the study	Day 8	Yes
Primary	Primary Analysis	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	Day 8	No