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

NCT01674530 | Completed Phase 3

• 1 other identifier: DRL-USG01-L/2012
• Study Type: interventional
• Target: 909
• Locations: 1 country
• Sites: 93

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

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Safety Analysis

  Day 8

Study Arms (3)

Lubiprostone

EXPERIMENTAL

Manufactured by Dr Reddy's Laboratories Ltd( 24 mcg administered for 7 days )

Drug: Lubiprostone

AMITIZA®

ACTIVE COMPARATOR

Manufactured by Sucampo Pharmaceuticals(24 mcg administered for 7 days)

Drug: Lubiprostone

Placebo

PLACEBO COMPARATOR

Manufactured by Dr Reddy's Laboratories Ltd ( 24 mcg adminstered for 7 days )

Drug: Placebo

Interventions

Lubiprostone DRUG

24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA

Lubiprostone

Placebo DRUG

24 mcg capsules of both experimental Lubiprostone and AMITIZA

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead
• Parexel: collaborator

Study Sites (93)

Radiant Research

Birmingham, Alabama, 35209, United States

Location

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

Drug Research Group, LLC

Mobile, Alabama, 36608, United States

Location

Radiant Research

Scottsdale, Arizona, 85251, United States

Location

Adobe Clinical Research , LLC

Tucson, Arizona, 85712, United States

Location

Visions Clinical Research

Tucson, Arizona, 85712, United States

Location

SC Clinical Research, Inc

Tucson, Arizona, 85741, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Diagnamics Inc,477 N. El Camino Real,Suite A100

Encinitas, California, 92024, United States

Location

Advanced Medical Research Institute

Fresno, California, 93710, United States

Location

Research Center of Fresno

Fresno, California, 93726, United States

Location

Translational Research Group

North Hollywood, California, 91606, United States

Location

Staywell Research

Northridge, California, v, United States

Location

Elias Research Associates

Orange, California, 92868, United States

Location

Benchmark Research

Sacramento, California, 95816, United States

Location

Medical Center for CR

San Diego, California, 92108, United States

Location

Shawn K Hassler

San Francisco, California, United States

Location

SC Clinical Research, Inc ,1060 E. Foothill Blvd, Suite 204

Upland, California, 91786, United States

Location

Progressive Clinical Research

Vista, California, 92084, United States

Location

Horizons Clinical Research Center

Denver, Colorado, 80220, United States

Location

Radiant Research

Denver, Colorado, 80239, United States

Location

Lynn Institute of Denver

Denver, Colorado, 80246, United States

Location

Consultants of Clinical

Boynton Beach, Florida, 33426, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Elite Trials

Clearwater, Florida, 33761, United States

Location

Health Care Family Rehabilitation and Research Center

Hialeah, Florida, 33012, United States

Location

Medical Research Unlimited, LLC

Hialeah, Florida, 33012, United States

Location

Health Awareness ,Inc

Jupiter, Florida, 33458, United States

Location

Sunrise Medical Research

Lauderdale Lakes, Florida, 33319, United States

Location

San Marcus Research Clinic

Miami, Florida, 33015, United States

Location

Pharmax Research Clinic

Miami, Florida, 33126, United States

Location

Community Research Foundation , Inc.

Miami, Florida, 33155, United States

Location

Florida International Research

Miami, Florida, 33166, United States

Location

Columbus Clinical Services

Miami, Florida, 33174, United States

Location

South Medical Research Group , Inc

Miami, Florida, 33186, United States

Location

Pharma Research International, Inc

Naples, Florida, 34109, United States

Location

Pharma Research International, Inc

Naples, Florida, 34110, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Ormond Medical Arts Pharmaceutical

Ormond Beach, Florida, 32174, United States

Location

Clinical Research of Central Florida

Plant City, Florida, 33563, United States

Location

Accord Clinical Research,LLC

Port Orange, Florida, 32129, United States

Location

Meridian Research

St. Petersburg, Florida, 33709, United States

Location

Meridian Research

Tampa, Florida, 33606, United States

Location

Clinical Research of Central Florida

Winter Haven, Florida, 33880, United States

Location

Mount Vernon Clinical Research

Atlanta, Georgia, 30328, United States

Location

Gastroenterology Consultants PC

Atlanta, Georgia, 30342, United States

Location

Atlanta Gastroenterology Assoc

Marietta, Georgia, 30067, United States

Location

Advanced Digestive Care Center , PC

Stockbridge, Georgia, 30281, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Heartland Research Associates

Newton, Kansas, 67114, United States

Location

Heartland Research Associates

Wichita, Kansas, 67205, United States

Location

Research Integrity

Owensboro, Kentucky, 42303, United States

Location

East Jefferson Gastro

Metairie, Louisiana, 70006, United States

Location

Boston Clinical Trials Inc

Boston, Massachusetts, 2131, United States

Location

Beacon Clinical Research

Brockton, Massachusetts, 02301, United States

Location

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, 2472, United States

Location

Clinical Research Institute

Chesterfield, Michigan, 48047, United States

Location

Bayer Research

Kalamazoo, Michigan, 49009, United States

Location

GI Associates and Endoscopy Center

Jackson, Mississippi, 39202, United States

Location

Quality Clinical Research, Inc

Omaha, Nebraska, 68114, United States

Location

Central Jersey Medical Research Center

Elizabeth, New Jersey, 07202, United States

Location

University Hospital,150 Bergen Street,B-134 Pharmacy

Newark, New Jersey, 07103, United States

Location

Hosc Inc.

Brooklyn, New York, 11206, United States

Location

NY Scientific,189-11 Jamaica Ave

Hollis, New York, 11423, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Valley Medical Research

Centerville, Ohio, 45459, United States

Location

Rapid Medical Research , Inc

Cleveland, Ohio, 44122, United States

Location

Radiant Research

Columbus, Ohio, 43212, United States

Location

Great Lakes Gastroenterology

Mentor, Ohio, 44060, United States

Location

Detweiler Family Medicine and Associates, PC

Lansdale, Pennsylvania, 19446, United States

Location

Clinical Trials Research Services, LLC

Pittsburgh, Pennsylvania, 15206, United States

Location

Radiant Research

Greer, South Carolina, 29650, United States

Location

Clinsearch LLC

Chattanooga, Tennessee, 37421, United States

Location

HCCA-CRS

Jackson, Tennessee, 38305, United States

Location

KRK Medical Research

Dallas, Texas, 75230, United States

Location

Gastroenterology Consultants P.A

Houston, Texas, 77034, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Digestive Health Center

Pasadena, Texas, 77505, United States

Location

Paragon Research Center

San Antonio, Texas, 78205, United States

Location

Quality Research, Inc

San Antonio, Texas, 78209, United States

Location

Sun Research

San Antonio, Texas, 78215, United States

Location

Texas Medical Research Associates , LLC

San Antonio, Texas, 78238, United States

Location

Breco Research

Sugarland, Texas, 77479, United States

Location

Pioneer Research Solutions , Inc

Sugarland, Texas, 77479, United States

Location

Charlottesville Medical Research Center

Charlottesville, Virginia, 22911, United States

Location

BlueRidge Medical Research

Lynchburg, Virginia, 24502, United States

Location

Health Research of Hampton Roads

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Interventions

Lubiprostone

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Ashis Patnaik, M.D

  Dr. Reddy's Laboratories Limited

  STUDY DIRECTOR

• Shilpi Dhawan, M.D

  Dr. Reddy's Laboratories Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 29, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 3, 2014

Record last verified: 2012-08

Locations

US (93)