Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01674530
First received: August 21, 2012
Last updated: April 2, 2014
Last verified: August 2012
  Purpose

The objective of this study is to evaluate the clinical equivalence and safety of the test formulation of Lubiprostone 24 mcg capsules manufactured by Dr Reddy's Laboratories Ltd 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,Randomized , Double-blind,Double -Dummy Placebo-controlled,Parallel -Group, Multicenter Study to Evaluate the Clinical Equivalence of Lubiprostone 24 mcg Capsules ( Dr. Reddy's Laboratories Ltd.) 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 Dr. Reddy's Laboratories Limited:

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 treatment period of the study


Other Outcome Measures:
  • Safety Analysis [ Time Frame: Day 8 ] [ Designated as safety issue: Yes ]
    The type , frequency and severity of adverse events across the treatment groups will be analyzed at the end of the study


Enrollment: 909
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubiprostone
Manufactured by Dr Reddy's Laboratories Ltd( 24 mcg administered for 7 days )
Drug: Lubiprostone
24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA
Active Comparator: AMITIZA®
Manufactured by Sucampo Pharmaceuticals(24 mcg administered for 7 days)
Drug: Lubiprostone
24 mcg Capsules with placebo of Lubiprostone ( Manufactured by Dr Reddy's Laboratories Ltd)
Placebo Comparator: Placebo
Manufactured by Dr Reddy's Laboratories Ltd ( 24 mcg adminstered for 7 days )
Drug: Placebo
24 mcg capsules of both experimental Lubiprostone and AMITIZA

Detailed Description:

Constipation is a common gastrointestinal problem estimated to effect 2-27 % of the population in United States . It is found more commonly in women and elderly . The prevelance of constipation and growing demand for treatment dictate the need for safe and effective treatment options . Lubiprostone is the first chloride channel activator approved by FDA for long term treatment of chronic idiopathic constipation in adult men and women . To provide a generic medicine to the U.S population Dr Reddy's Laboratories intends to conduct this study to evaluate that the Lubiprostone manufactured by it is equally effective and safe as marketed AMITIZA® ( Lubiprostone) 24 mcg capsules (Sucampo Pharmaceuticals, Inc.)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Patients who have signed the written informed consent form prior to entering the study.
  2. Male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of CIC defined as, on average, < 3 SBMs per week and confirmed by daily diary during the two week baseline/washout period. An SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use.
  3. Patients with body mass index between 18 and 35kg/m2 (both inclusive)
  4. Have one or more of the following symptoms related to BMs for at least 6 months before the baseline visit and confirmed by daily diary during the 2 weeks baseline/washout period:

    i. very hard (little balls) and/or hard stools for at least 25% of the bowel movements ii. sensation of incomplete evacuation following at least 25% of the bowel movements iii. straining at defecation at least a quarter of the time

  5. Women of child-bearing potential should have a negative serum pregnancy test prior to beginning therapy and agree to use effective contraceptive methods (at least one medically approved and highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, oral contraceptives combined with at least one barrier method, hormonal IUDs, sexual abstinence or vasectomy of the partner) during the study.
  6. For patients aged < 50 years, documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within the five years prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.
  7. For patients aged ≥ 50 years, documentation of the results of either a barium enema with flexible sigmoidoscopy or colonoscopy performed within one year prior to dosing, showing no mechanical bowel obstruction or organic disorders of the large or small bowel.

Main Exclusion Criteria:

  1. Females who are pregnant, breast feeding, or planning a pregnancy during the proposed study period.
  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 who have documented mechanical bowel obstruction (e.g., bowel obstruction due to tumor, hernia), megacolon/megarectum, or diagnosis of pseudo-obstruction.
  4. Patients with 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 or with neurologic diseases or other diseases that cause motility problems for example Parkinson's disease and spinal cord injury, etc.
  5. Patients with a history of bowel resection.
  6. Patients who are regularly using medications, which are known to cause constipation (anticholinergics, narcotics, calcium channel blockers, tricyclic antidepressants, colchicine, iron supplements, magnesium supplements).
  7. Patients who are hospitalized for any gastrointestinal or abdominal surgical procedure during the three months prior to dosing.
  8. Patients with clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or clinically significant laboratory abnormalities (if laboratory values exceed 2X Upper Limit of Normal the approval of medical monitor should be taken into consideration before randomizing the patient).
  9. Use of systemic antibiotics within four weeks prior to baseline.
  10. Any current or planned significant change in diet during the study.
  11. Participation in a study with any investigational medication within the past 30 days before 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: NCT01674530

  Show 93 Study Locations
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Parexel
Investigators
Study Director: Ashis Patnaik, M.D Dr Reddy's Laboratories Ltd.
Study Director: Shilpi Dhawan, M.D Dr Reddy's Laboratories Ltd.
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01674530     History of Changes
Other Study ID Numbers: DRL-USG01-L/2012
Study First Received: August 21, 2012
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014