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

Anchen Pharmaceuticals, Inc2 sites in 1 country808 target enrollmentMay 2011

ConditionsChronic Idiopathic Constipation

InterventionsLubiprostone Placebo

DrugsLubiprostone Placebo

Overview

Phase: Phase 3
Intervention: Lubiprostone
Conditions: Chronic Idiopathic Constipation
Sponsor: Anchen Pharmaceuticals, Inc
Enrollment: 808
Locations: 2
Primary Endpoint: Primary Analysis
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

June 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anchen Pharmaceuticals, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Arms & Interventions

AMITIZA

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

Intervention: Lubiprostone

Placebo

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

Intervention: Placebo

Lubiprostone

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

Intervention: Lubiprostone

Outcomes

Primary Outcomes

Primary Analysis

Time Frame: Day 8

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.