Evaluation of Clinical Equivalence Between Two Lubiprostone Products

Chronic Idiopathic Constipation Clinical Trial

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

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

• Chronic Idiopathic Constipation
• Constipation

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