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Clinical Trials/NCT01443403
NCT01443403CompletedPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy

Shionogi1 site in 1 country244 target enrollmentStarted: August 17, 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
244
Locations
1
Primary Endpoint
Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation
  • •Subjects with < 3 spontaneous bowel movements a week and experiencing bowel symptoms
  • •Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months

Exclusion Criteria

  • •Evidence of clinically significant gastrointestinal disease
  • •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
  • •Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation

Arms & Interventions

Placebo

Placebo Comparator

Participants received placebo orally once daily for 28 days.

Intervention: Placebo (Drug)

Naldemedine 0.1 mg

Experimental

Participants received 0.1 mg naldemedine orally once daily for 28 days.

Intervention: Naldemedine (Drug)

Naldemedine 0.2 mg

Experimental

Participants received 0.2 mg naldemedine orally once daily for 28 days.

Intervention: Naldemedine (Drug)

Naldemedine 0.4 mg

Experimental

Participants received 0.4 mg naldemedine orally once daily for 28 days.

Intervention: Naldemedine (Drug)

Outcomes

Primary Outcomes

Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week

Time Frame: Baseline (2 weeks prior to randomization) and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)

Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation. A spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per week during the 2 weeks prior to randomization. The number of SBMs per week in the last 2 weeks of treatment is defined as the average number of SBMs per week recorded in the diary for the 14 days prior to the last dose of study drug.

Secondary Outcomes

  • Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Spontaneous Bowel Movements Per Week(Baseline and Weeks 1, 2, 3, and 4)
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Bowel Movements (BMs) Per Week(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Bowel Movements Per Week(Baseline and Weeks 1, 2, 3, and 4)
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Bowel Movements (CBMs) Per Week(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Bowel Movements Per Week(Baseline and Weeks 1, 2, 3, and 4)
  • Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Spontaneous Bowel Movements Per Week(Baseline and Weeks 1, 2, 3, and 4)
  • Percentage of Participants With an SBM Response in the Last 2 Weeks of the Treatment Period(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Percentage of Participants With an SBM Response at Weeks 1, 2, 3 and 4(Baseline and Weeks 1, 2, 3, and 4)
  • Percentage of Participants With a CSBM Response in the Last 2 Weeks of the Treatment Period(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Percentage of Participants With a CSBM Response at Weeks 1, 2, 3, and 4(Baseline and Weeks 1, 2, 3, and 4)
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With SBMs(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With SBMs(Baseline and Weeks 1, 2, 3, and 4)
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With CSBMs(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With CSBMs(Baseline and Weeks 1, 2, 3, and 4)
  • Time to the First Spontaneous Bowel Movement(28 days)
  • Time to the First Complete Spontaneous Bowel Movement(28 days)
  • Percentage of Participants With SBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug(4, 8, 12, and 24 hours)
  • Percentage of Participants With CSBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug(4, 8, 12, and 24 hours)
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week Rated as 3 or 4 on the Bristol Stool Scale(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to Weeks 1, 2, 3, and 4 in Number of SBMs Rated as 3 or 4 on the Bristol Stool Scale Per Week(Baseline and Weeks 1, 2, 3, and 4)
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week With no Straining(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of SBMs Per Week Without Straining(Baseline and Weeks 1, 2, 3, and 4)
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of False Start BMs Per Week(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in Rescue Use of Laxative Agents Per Week(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Mean Rescue Laxative Use Per Week During the Treatment Period(Weeks 1 to 4)
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Bloating(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Bloating(Baseline and Weeks 1, 2, 3, and 4)
  • Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Discomfort(Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period))
  • Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Discomfort(Baseline and Weeks 1, 2, 3, and 4)
  • Subject Global Satisfaction at End of Treatment(Day 29, or at early termination)
  • Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995(Day 1 and Day 28 predose and 1, 2, 4, 8, and 24 hours postdose)
  • Time to Maximum Concentration (Tmax) of Naldemedine and Metabolite Nor-S-297995(Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose)
  • Area Under the Concentration-time Curve From Hour 0 to the Time Point of the Last Measurable Concentration Within the Dose Interval (AUC0-τ)(Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose)
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From first dose of study drug through 28 days after the last dose of study treatment (up to 57 days).)

Investigators

Sponsor
Shionogi
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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A Study of Naldemedine (S-297995) for the... | Clinical Trial