Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation

Opioid-induced Constipation Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Naldemedine in the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993940
• Other study ID #: 1315V9232
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2013
• Last updated: May 5, 2016
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in subjects with non-malignant chronic pain who are not using laxatives

Description:

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of naldemedine 0.2 mg once daily versus placebo for the treatment of subjects with non-malignant chronic pain and OIC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects aged 18 to 80 years inclusive at the time of informed consent

• Subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (OIC)

• Subjects must be treated with a stable opioid regimen at a total daily dose on average of = 30 mg equivalents of oral morphine sulfate

• Subjects must not be currently using laxatives or must be willing to discontinue laxative use at Screening and must be willing to use only the rescue laxatives provided throughout the study duration

• Subjects must meet opioid-induced constipation criteria based on the Bowel Movement and Constipation Assessment (BMCA) Diary

Exclusion Criteria:

• Evidence of significant structural abnormalities of the gastrointestinal (GI) tract

• Evidence of active medical diseases affecting bowel transit

• History or presence of pelvic disorders that may be a cause of constipation

• Surgery (except for minor procedures) within 60 days of Screening

• History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical GI obstruction)

• Subjects who have never taken laxatives for the treatment of OIC

• History of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen [Nolvadex®] and raloxifene [Evista®] when being used for prevention of breast cancer

• Current use of any prohibited medication including opioid antagonists, partial agonists, or mixed agonists/antagonists

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Opioid-induced Constipation

Intervention

Drug:
• Naldemedine
Naldemedine tablet from weeks 1-12
• Placebo
Placebo tablet from weeks 1- 12

Locations

Country	Name	City	State
United States	Shionogi Research Site	Albuquerque	New Mexico
United States	Shionogi Research Site	Anaheim	California
United States	Shionogi Research Site	Birmingham	Alabama
United States	Shionogi Research Site	Buena Park	California
United States	Shionogi Research Site	Butte	Montana
United States	Shionogi Research Site	Channelview	Texas
United States	Shionogi Research Site	Chesapeake	Virginia
United States	Shionogi Research Site	Chester	Virginia
United States	Shionogi Research Site	Clarksburg	West Virginia
United States	Shionogi Research Site	Columbus	Georgia
United States	Shionogi Research Site	Coral Gables	Florida
United States	Shionogi Research Site	Corona	California
United States	Shionogi Research Site	Crowley	Louisiana
United States	Shionogi Research Site	Dayton	Ohio
United States	Shionogi Research Site	Edgewood	Kentucky
United States	Shionogi Research Site	Evansville	Indiana
United States	Shionogi Research Site	Forth Worth	Texas
United States	Shionogi Research Site	Gold River	California
United States	Shionogi Research Site	Goodyear	Arizona
United States	Shionogi Research Site	Groesbeck	Texas
United States	Shionogi Research Site	Hialeah	Florida
United States	Shionogi Research Site	Homewood	Alabama
United States	Shionogi Research Site	Hopewell Junction	New York
United States	Shionogi Research Site	Houston	Texas
United States	Shionogi Research Site	Indianapolis	Indiana
United States	Shionogi Research Site	Jacksonville	Florida
United States	Shionogi Research Site	Kalamazoo	Michigan
United States	Shionogi Research Site	Knoxville	Tennessee
United States	Shionogi Research Site	Las Vegas	Nevada
United States	Shionogi Research Site	Little Rock	Arkansas
United States	Shionogi Research Site	Los Angeles	California
United States	Shionogi Research Site	Marion	Ohio
United States	Shionogi Research Site	Media	Pennsylvania
United States	Shionogi Research Site	Miami	Florida
United States	Shionogi Research Site	Miami Beach	Florida
United States	Shionogi Research Site	Modesto	California
United States	Shionogi Research Site	Mooresville	North Carolina
United States	Shionogi Research Site	Omaha	Nevada
United States	Shionogi Research Site	Omaha	Nebraska
United States	Shionogi Research Site	Pasadena	California
United States	Shionogi Research Site	Plano	Texas
United States	Shionogi Research Site	Plantation	Florida
United States	Shionogi Research Site	San Antonio	Texas
United States	Shionogi Research Site	Spartanburg	South Carolina
United States	Shionogi Research Site	Tacoma	Washington
United States	Shionogi Research Site	Traverse City	Michigan
United States	Shionogi Research Site	Tullahoma	Tennessee
United States	Shionogi Research Site	West Des Moines	Iowa
United States	Shionogi Research Site	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of responders	The primary efficacy endpoint will be the proportion of responders where a responder is defined as of having 9 positive response weeks or more out of the 12 week Treatment Period and 3 positive response weeks out of last 4 weeks of the 12 week Treatment Period. A positive response week will be defined as = 3 spontaneous bowel movements (SBMs) per week and an increase from baseline of = 1 SBM per week for that week.	12-week treatment period	No