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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01372423
Other study ID # CS-01-2011
Secondary ID 71060001
Status Completed
Phase Phase 3
First received June 10, 2011
Last updated July 10, 2012
Start date May 2011
Est. completion date June 2012

Study information

Verified date July 2012
Source Anchen Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
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 compared to the marketed formulation AMITIZA® (lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.) in patients with confirmed chronic idiopathic constipation.


Recruitment information / eligibility

Status Completed
Enrollment 808
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

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


Intervention

Drug:
Lubiprostone
24 mcg capsules
Placebo
24 mcg capsules

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Anchen Pharmaceuticals, Inc Novum Pharmaceutical Research Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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 randomization period of the study. Day 8 No
Secondary Safety Analysis The frequency and severity of adverse events across treatment groups will be analyzed. Day 8 Yes
See also
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