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

Recruiting at91 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Dr. Reddy's Laboratories Limited

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Ashis Patnaik, M.D

Principal Investigator

Dr. Reddy's Laboratories Limited

Shilpi Dhawan, M.D

Principal Investigator

Dr. Reddy's Laboratories Limited

Eligibility Criteria

Inclusion Criteria

Patients who have signed the written informed consent form prior to entering the study.

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.

Patients with body mass index between 18 and 35kg/m2 (both inclusive)

Treatment Details

Interventions

• Lubiprostone (Chloride Channel Activator)

Participant Groups

Group I: Lubiprostone Experimental Treatment 1 Intervention

Manufactured by Dr Reddy's Laboratories Ltd( 24 mcg administered for 7 days )

Group II: AMITIZA® Active Control 1 Intervention

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

Group III: Placebo Placebo Group 1 Intervention

Manufactured by Dr Reddy's Laboratories Ltd ( 24 mcg adminstered for 7 days )

Who Is Running the Clinical Trial?

Dr. Reddy's Laboratories Limited

Lead Sponsor

Trials

237

Recruited

47,600+

Erez Israeli

Dr. Reddy's Laboratories Limited

Chief Executive Officer since 2019

Graduated in Chemical Engineering from Osmania University, India; M.S. in Medical Chemistry from Purdue University, USA

Dr. Ranjana Pathak

Dr. Reddy's Laboratories Limited

Chief Medical Officer since 2022

MD from Osmania University

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland