Clinical trial NCT01372423: Evaluation of Clinical Equivalence Between Two Lubiprostone Products
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Idiopathic Constipation
Lead sponsor: Anchen Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Novum Pharmaceutical Research Services
First posted: 2011-06-14
Enrollment: 808
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 compared to the marketed formulation AMITIZA® (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed chronic idiopathic constipation.


Eligibility criteria: Main Inclusion Criteria:

1. 1. 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.
2. 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
3. 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.
4. 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.
5. 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.

Main Exclusion Criteria:

1. Females who are Pregnant, breast feeding, or planning a pregnancy.
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 that have documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.
4. 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.
5. History of bowel resection.
6. Patients who are regularly using medications know to cause constipation (narcotics, calcium channel blockers, tricyclic antidepressants).
7. Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing.
8. Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities.
9. Use of a systemic antibiotic within 4 weeks prior to the Screening Visit.
10. Participation in a study with any investigational medication within the past 30 days of screening for this study or previous participation in this study.

Primary outcomes:
measure: Primary Analysis
timeFrame: Day 8
Secondary outcomes:
measure: Safety Analysis
timeFrame: Day 8
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Novum Investigator Site
state: Alabama
city: Huntsville
country: United States
facility: Novum Investigator Site
state: Alabama
city: Mobil
country: United States
facility: Novum Investigator Site
state: Alabama
city: Chandler
country: United States
facility: Novum Investigator Site
state: Arizona
city: Gilbert
country: United States
facility: Novum Investigator Site
state: Arizona
city: Mesa
country: United States
facility: Novum Investigator Site
state: Arizona
city: Phoenix
country: United States
facility: Novum Investigator Site
state: Arizona
city: Phoeniz
country: United States
facility: Novum Investigator Site
state: Arizona
city: Hot Springs
country: United States
facility: Novum Investigator Site
state: Arkansas
city: Little Rock
country: United States
facility: Novum Investigator Site
state: Arkansas
city: Mountain Home
country: United States
facility: Novum Investigator Site
state: Arkansas
city: Sherwood
country: United States
facility: Novum Investigator Site
state: Arkansas
city: Buena Park
country: United States
facility: Novum Investigator Site
state: California
city: Fresno
country: United States
facility: Novum Investigator Site
state: California
city: Garden Grove
country: United States
facility: Novum Investigator Site
state: California
city: La Palma
country: United States
facility: Novum Investigator Site
state: California
city: Long Beach
country: United States
facility: Novum Investigator Site
state: California
city: Sacremento
country: United States
facility: Novum Investigator Site
state: California
city: San Diego
country: United States
facility: Novum Investigator Site
state: California
city: San Ramon
country: United States
facility: Novum Invesitgator Site
state: California
city: Santa Ana
country: United States
facility: Novum Investigator Site
state: California
city: Westlake Village
country: United States
facility: Novum Investigator Site
state: California
city: Denver
country: United States
facility: Novum Investigator Site
state: Colorado
city: WheatRidge
country: United States
facility: Novum Investigator Site
state: Colorado
city: Adventura
country: United States
facility: Novum Investigator Site
state: Florida
city: Boyton Beach
country: United States
facility: Novum Investigator Site
state: Florida
city: Bradenton
country: United States
facility: Novum Investigator Site
state: Florida
city: Brookville
country: United States
facility: Novum Investigator Site
state: Florida
city: Clearwater
country: United States
facility: Novum Investigator Site
state: Florida
city: Deerfield Beach
country: United States
facility: Novum Investigator Site
state: Florida
city: Jupiter
country: United States
facility: Novum Investigator Site
state: Florida
city: Maimi
country: United States
facility: Novum Investigator Site
state: Florida
city: Miami
country: United States
facility: Novum Investigator Site
state: Florida
city: Niceville
country: United States
facility: Novum Investigator Site
state: Florida
city: Ormond Beach
country: United States
facility: Novum Investigator Site
state: Florida
city: Panama City
country: United States
facility: Novum Investigator Site
state: Florida
city: Port Orange
country: United States
facility: Novum Investigator Site
state: Florida
city: St. Petersburg
country: United States
facility: Novum Investigator Site
state: Florida
city: Tampa
country: United States
facility: Novum Investigator Site
state: Florida
city: West Palm Beach
country: United States
facility: Novum Investigator Site
state: Florida
city: Decauter
country: United States
facility: Novum Investigator Site
state: Georgia
city: Sandy Springs
country: United States
facility: Novum Investigator Site
state: Georgia
city: Stockbridge
country: United States
facility: Novum Investigator Site
state: Georgia
city: Lewiston
country: United States
facility: Novum Investigator Site
state: Idaho
city: Rockford
country: United States
facility: Novum Investigator Site
state: Illinois
city: Evansville
country: United States
facility: Novum Investigator Site
state: Indiana
city: Lexington
country: United States
facility: Novum Investigator Site
state: Kentucky
city: Shreveport
country: United States
facility: Novum Investigator Site
state: Louisiana
city: Hollywood
country: United States
facility: Novum Invesitgator Site
state: Maryland
city: Jackson
country: United States
facility: Novum Investigator Site
state: Mississippi
city: Mexico
country: United States
facility: Novum Investigator Site
state: Missouri
city: Washington
country: United States
facility: Novum Investigator Site
state: Missouri
city: Billings
country: United States
facility: Novum Investigator Site
state: Montana
city: Lincoln
country: United States
facility: Novum Investigator Site
state: Nebraska
city: Henderson
country: United States
facility: Novum Investigator Site
state: Nevada
city: Marlton
country: United States
facility: Novum Investigator Site
state: New Jersey
city: Newport News
country: United States
facility: Novum Investigator Site
state: New Jersey
city: Poughkeepsie
country: United States
facility: Novum Investigator Site
state: New York
city: Cary
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Charlotte
country: United States
facility: Novum Investigator Site
state: North Carolina
city: High Point
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Raleigh
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Salisbury
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Wilmington
country: United States
facility: Novum Investigator Site
state: North Carolina
city: Winstom-Salem
country: United States
facility: Novum Investigator Site
state: North Carolina
city: BeaverCreek
country: United States
facility: Novum Investigator Site
state: Ohio
city: Centerville
country: United States
facility: Novum Investigator Site
state: Ohio
city: Sylvania
country: United States
facility: Novum Investigator Site
state: Ohio
city: Columbia
country: United States
facility: Novum Investigator Site
state: South Carolina
city: Chattanooga
country: United States
facility: Novum Investigator Site
state: Tennessee
city: Germantown
country: United States
facility: Novum Investigator Site
state: Tennessee
city: Hermitage
country: United States
facility: Novum Investigator Site
state: Tennessee
city: Houston
country: United States
facility: Novum Investigator Site
state: Texas
city: Longview
country: United States
facility: Novum Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Novum Investigator Site
state: Texas
city: Sugarland
country: United States
facility: Novum Investigator Site
state: Texas
city: Charlottesville
country: United States
facility: Novum Investigator Site
state: Virginia
city: Virginia Beach
country: United States
facility: Novum Investigator Site
state: Virginia
city: Mountain Lake
country: United States
facility: Novum Investigator Site
state: Washington
Study officials:
References: