Evaluation of Clinical Equivalence Between Two Lubiprostone Products
A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Evaluate the Clinical Equivalence of Lubiprostone 24 Mcg Capsules (Anchen Pharmaceuticals, Inc.) With AMITIZA® (Lubiprostone) 24 Mcg Capsules (Sucampo Pharmaceuticals, Inc.) in the Treatment of Chronic Idiopathic Constipation
2 other identifiers
interventional
808
1 country
79
Brief Summary
The objective of this study is to evaluate the clinical equivalence and safety of the Test formulation of lubiprostone 24 mcg capsules compared to the marketed formulation AMITIZA® (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed chronic idiopathic constipation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2011
Shorter than P25 for phase_3
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 12, 2012
July 1, 2012
1.1 years
June 10, 2011
July 10, 2012
Conditions
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 randomization period of the study.
Day 8
Secondary Outcomes (1)
Safety Analysis
Day 8
Study Arms (3)
AMITIZA
ACTIVE COMPARATORManufactured by Sucampo Pharmaceuticals (24 mcg administered for 7 days)
Placebo
PLACEBO COMPARATORManufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days)
Lubiprostone
EXPERIMENTALManufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days)
Interventions
Eligibility Criteria
You may qualify if:
- \. Male or non-pregnant females aged 18 and older with a clinical diagnosis of chronic idiopathic constipation defined as, on average, \< 3 spontaneous bowel movements (SBMs) per week for the past 6 months and confirmed by daily diary during the 14 day baseline lead-in period. An SBM is defined as any bowel movement that did not occur within 24 hours after rescue medication use.
- Have 1 or more of the following symptoms related to bowel movements for at least 6 months before the baseline visit and confirmed by daily diary during the 14 Day baseline period:
- very hard (little balls) and/or hard stools for at least 25 percent of the bowel movements
- sensation of incomplete evacuation following at least 25 percent of the bowel movements
- straining at defecation at least a quarter of the time
- Women of child-bearing potential must have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study.
- For patients aged \< 50 years, documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within the 5 years prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large Bowel.
- For patients aged \>/= 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within 1 year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large bowel.
You may not qualify if:
- Females who are Pregnant, breast feeding, or planning a pregnancy.
- 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 that have documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.
- Any 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.
- History of bowel resection.
- Patients who are regularly using medications know to cause constipation (narcotics, calcium channel blockers, tricyclic antidepressants).
- Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing.
- Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities.
- Use of a systemic antibiotic within 4 weeks prior to the Screening Visit.
- Participation in a study with any investigational medication within the past 30 days of screening for this study or previous participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
Novum Investigator Site
Dothan, Alabama, United States
Novum Investigator Site
Huntsville, Alabama, United States
Novum Investigator Site
Mobile, Alabama, United States
Novum Investigator Site
Chandler, Arizona, United States
Novum Investigator Site
Gilbert, Arizona, United States
Novum Investigator Site
Mesa, Arizona, United States
Novum Investigator Site
Phoenix, Arizona, United States
Novum Investigator Site
Phoeniz, Arizona, United States
Novum Investigator Site
Hot Springs, Arkansas, United States
Novum Investigator Site
Little Rock, Arkansas, United States
Novum Investigator Site
Mountain Home, Arkansas, United States
Novum Investigator Site
Sherwood, Arkansas, United States
Novum Investigator Site
Buena Park, California, United States
Novum Investigator Site
Fresno, California, United States
Novum Investigator Site
Garden Grove, California, United States
Novum Investigator Site
La Palma, California, United States
Novum Investigator Site
Long Beach, California, United States
Novum Investigator Site
Sacremento, California, United States
Novum Investigator Site
San Diego, California, United States
Novum Invesitgator Site
San Ramon, California, United States
Novum Investigator Site
Santa Ana, California, United States
Novum Investigator Site
Westlake Village, California, United States
Novum Investigator Site
Denver, Colorado, United States
Novum Investigator Site
Wheat Ridge, Colorado, United States
Novum Investigator Site
Adventura, Florida, United States
Novum Investigator Site
Boyton Beach, Florida, United States
Novum Investigator Site
Bradenton, Florida, United States
Novum Investigator Site
Brookville, Florida, United States
Novum Investigator Site
Clearwater, Florida, United States
Novum Investigator Site
Deerfield Beach, Florida, United States
Novum Investigator Site
Jupiter, Florida, United States
Novum Investigator Site
Maimi, Florida, United States
Novum Investigator Site
Miami, Florida, United States
Novum Investigator Site
Niceville, Florida, United States
Novum Investigator Site
Ormond Beach, Florida, United States
Novum Investigator Site
Panama City, Florida, United States
Novum Investigator Site
Port Orange, Florida, United States
Novum Investigator Site
St. Petersburg, Florida, United States
Novum Investigator Site
Tampa, Florida, United States
Novum Investigator Site
West Palm Beach, Florida, United States
Novum Investigator Site
Decauter, Georgia, United States
Novum Investigator Site
Sandy Springs, Georgia, United States
Novum Investigator Site
Stockbridge, Georgia, United States
Novum Investigator Site
Lewiston, Idaho, United States
Novum Investigator Site
Rockford, Illinois, United States
Novum Investigator Site
Evansville, Indiana, United States
Novum Investigator Site
Lexington, Kentucky, United States
Novum Investigator Site
Shreveport, Louisiana, United States
Novum Invesitgator Site
Hollywood, Maryland, United States
Novum Investigator Site
Jackson, Mississippi, United States
Novum Investigator Site
Mexico, Missouri, United States
Novum Investigator Site
Washington, Missouri, United States
Novum Investigator Site
Billings, Montana, United States
Novum Investigator Site
Lincoln, Nebraska, United States
Novum Investigator Site
Henderson, Nevada, United States
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Marlton, New Jersey, United States
Novum Investigator Site
Newport News, New Jersey, United States
Novum Investigator Site
Poughkeepsie, New York, United States
Novum Investigator Site
Cary, North Carolina, United States
Novum Investigator Site
Charlotte, North Carolina, United States
Novum Investigator Site
High Point, North Carolina, United States
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Raleigh, North Carolina, United States
Novum Investigator Site
Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
Novum Investigator Site
Winstom-Salem, North Carolina, United States
Novum Investigator Site
Beavercreek, Ohio, United States
Novum Investigator Site
Centerville, Ohio, United States
Novum Investigator Site
Sylvania, Ohio, United States
Novum Investigator Site
Columbia, South Carolina, United States
Novum Investigator Site
Chattanooga, Tennessee, United States
Novum Investigator Site
Germantown, Tennessee, United States
Novum Investigator Site
Hermitage, Tennessee, United States
Novum Investigator Site
Houston, Texas, United States
Novum Investigator Site
Longview, Texas, United States
Novum Investigator Site
San Antonio, Texas, United States
Novum Investigator Site
Sugarland, Texas, United States
Novum Investigator Site
Charlottesville, Virginia, United States
Novum Investigator Site
Virginia Beach, Virginia, United States
Novum Investigator Site
Mountain Lake, Washington, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
June 10, 2011
First Posted
June 14, 2011
Study Start
May 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
July 12, 2012
Record last verified: 2012-07