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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: Lubiprostone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 808
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Dothan, Alabama, United States
      • Novum Investigator Site
    • Huntsville, Alabama, United States
      • Novum Investigator Site
    • Mobil, Alabama, United States
      • Novum Investigator Site
  • Arizona
    • 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
  • Arkansas
    • 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
  • California
    • 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 Investigator Site
    • San Ramon, California, United States
      • Novum Invesitgator Site
    • Santa Ana, California, United States
      • Novum Investigator Site
    • Westlake Village, California, United States
      • Novum Investigator Site
  • Colorado
    • Denver, Colorado, United States
      • Novum Investigator Site
    • WheatRidge, Colorado, United States
      • Novum Investigator Site
  • Florida
    • 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
  • Georgia
    • Decauter, Georgia, United States
      • Novum Investigator Site
    • Sandy Springs, Georgia, United States
      • Novum Investigator Site
    • Stockbridge, Georgia, United States
      • Novum Investigator Site
  • Idaho
    • Lewiston, Idaho, United States
      • Novum Investigator Site
  • Illinois
    • Rockford, Illinois, United States
      • Novum Investigator Site
  • Indiana
    • Evansville, Indiana, United States
      • Novum Investigator Site
  • Kentucky
    • Lexington, Kentucky, United States
      • Novum Investigator Site
  • Louisiana
    • Shreveport, Louisiana, United States
      • Novum Investigator Site
  • Maryland
    • Hollywood, Maryland, United States
      • Novum Invesitgator Site
  • Mississippi
    • Jackson, Mississippi, United States
      • Novum Investigator Site
  • Missouri
    • Mexico, Missouri, United States
      • Novum Investigator Site
    • Washington, Missouri, United States
      • Novum Investigator Site
  • Montana
    • Billings, Montana, United States
      • Novum Investigator Site
  • Nebraska
    • Lincoln, Nebraska, United States
      • Novum Investigator Site
  • Nevada
    • Henderson, Nevada, United States
      • Novum Investigator Site
  • New Jersey
    • Marlton, New Jersey, United States
      • Novum Investigator Site
    • Newport News, New Jersey, United States
      • Novum Investigator Site
  • New York
    • Poughkeepsie, New York, United States
      • Novum Investigator Site
  • North Carolina
    • Cary, North Carolina, United States
      • Novum Investigator Site
    • Charlotte, North Carolina, United States
      • Novum Investigator Site
    • High Point, North Carolina, United States
      • Novum Investigator Site
    • Raleigh, North Carolina, United States
      • Novum Investigator Site
    • Salisbury, North Carolina, United States
      • Novum Investigator Site
    • Wilmington, North Carolina, United States
      • Novum Investigator Site
    • Winstom-Salem, North Carolina, United States
      • Novum Investigator Site
  • Ohio
    • BeaverCreek, Ohio, United States
      • Novum Investigator Site
    • Centerville, Ohio, United States
      • Novum Investigator Site
    • Sylvania, Ohio, United States
      • Novum Investigator Site
  • South Carolina
    • Columbia, South Carolina, United States
      • Novum Investigator Site
  • Tennessee
    • Chattanooga, Tennessee, United States
      • Novum Investigator Site
    • Germantown, Tennessee, United States
      • Novum Investigator Site
    • Hermitage, Tennessee, United States
      • Novum Investigator Site
  • Texas
    • 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
  • Virginia
    • Charlottesville, Virginia, United States
      • Novum Investigator Site
    • Virginia Beach, Virginia, United States
      • Novum Investigator Site
  • Washington
    • Mountain Lake, Washington, United States
      • Novum Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AMITIZA; Manufactured by Sucampo Pharmaceuticals (24 mcg administered for 7 days)	Drug: Lubiprostone; 24 mcg capsules
Placebo Comparator: Placebo; Manufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days)	Drug: Placebo; 24 mcg capsules
Experimental: Lubiprostone; Manufactured by Anchen Pharmaceuticals (24 mcg administered for 7 days)	Drug: Lubiprostone; 24 mcg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Analysis	The frequency and severity of adverse events across treatment groups will be analyzed.	Day 8

Collaborators and Investigators

• Sponsor: Anchen Pharmaceuticals, Inc
• Collaborators: Novum Pharmaceutical Research Services

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 10, 2011
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Estimate): July 12, 2012
• Last Update Submitted That Met QC Criteria: July 10, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone
• Other Study ID Numbers: CS-01-2011; 71060001 (Other Identifier: Novum Pharmaceutical Research Services)