Evaluation of Clinical Equivalence Between Two Lubiprostone Products

This study has been completed.
Sponsor:
Collaborator:
Novum Pharmaceutical Research Services
Information provided by (Responsible Party):
Anchen Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01372423
First received: June 10, 2011
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Chronic Idiopathic Constipation
Drug: Lubiprostone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Anchen Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Primary Analysis [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Safety Analysis [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
    The frequency and severity of adverse events across treatment groups will be analyzed.


Enrollment: 808
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372423

  Show 79 Study Locations
Sponsors and Collaborators
Anchen Pharmaceuticals, Inc
Novum Pharmaceutical Research Services
  More Information

No publications provided

Responsible Party: Anchen Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01372423     History of Changes
Other Study ID Numbers: CS-01-2011, 71060001
Study First Received: June 10, 2011
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014