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A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy

NCT ID: NCT01443403

Last Updated: 2017-06-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-17

Study Completion Date

2012-08-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid-induced Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants received placebo orally once daily for 28 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo tablets administered orally once a day.

Naldemedine 0.1 mg

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

Group Type EXPERIMENTAL

Naldemedine

Intervention Type DRUG

Naldemedine tablets administered orally once a day.

Naldemedine 0.2 mg

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

Group Type EXPERIMENTAL

Naldemedine

Intervention Type DRUG

Naldemedine tablets administered orally once a day.

Naldemedine 0.4 mg

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

Group Type EXPERIMENTAL

Naldemedine

Intervention Type DRUG

Naldemedine tablets administered orally once a day.

Interventions

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Placebo

Matching placebo tablets administered orally once a day.

Intervention Type DRUG

Naldemedine

Naldemedine tablets administered orally once a day.

Intervention Type DRUG

Other Intervention Names

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S 297995 Symproic®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shionogi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shionogi Clinical Trials Administrator Clinical Support Help Line

Role: STUDY_DIRECTOR

Shionogi

Locations

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Shionogi Research Site

Phoenix, Arizona, United States

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Shionogi Research Site

Sun Lakes, Arizona, United States

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Shionogi Research Site

Little Rock, Arkansas, United States

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Shionogi Research Site

Anaheim, California, United States

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Fresno, California, United States

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Lincoln, California, United States

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Lomita, California, United States

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Shionogi Research Site

Denver, Colorado, United States

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Shionogi Research Site

Brandon, Florida, United States

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Shionogi Research Site

Kissimmee, Florida, United States

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New Port Richey, Florida, United States

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North Miami, Florida, United States

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Ocala, Florida, United States

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Shionogi Research Site

Orlando, Florida, United States

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Shionogi Research Site

Ormond Beach, Florida, United States

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Shionogi Research Site

Port Orange, Florida, United States

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Shionogi Research Site

Sarasota, Florida, United States

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South Miami, Florida, United States

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Shionogi Research Site

West Palm Beach, Florida, United States

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Shionogi Research Site

Atlanta, Georgia, United States

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Shionogi Research Site

Decatur, Georgia, United States

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Shionogi Research Site

Marietta, Georgia, United States

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Shionogi Research Site

Evansville, Indiana, United States

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Shionogi Research Site

Lexington, Kentucky, United States

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Shionogi Research Site

Shreveport, Louisiana, United States

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Shionogi Research Site

Owings Mills, Maryland, United States

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Shionogi Research Site

Watertown, Massachusetts, United States

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Shionogi Research Site

Worcester, Massachusetts, United States

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Shionogi Research Site

Traverse City, Michigan, United States

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Shionogi Research Site

Edina, Minnesota, United States

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Shionogi Research Site

Las Vegas, Nevada, United States

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Shionogi Research Site

Newington, New Hampshire, United States

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Shionogi Research Site

Berlin, New Jersey, United States

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Shionogi Research Site

Willingboro, New Jersey, United States

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Shionogi Research Site

Hartsdale, New York, United States

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Shionogi Research Site

North Syracuse, New York, United States

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Shionogi Research Site

Williamsville, New York, United States

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Wilmington, North Carolina, United States

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Shionogi Research Site

Winston-Salem, North Carolina, United States

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Shionogi Research Site

Canton, Ohio, United States

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Shionogi Research Site

Columbus, Ohio, United States

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Shionogi Research Site

Perrysburg, Ohio, United States

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Shionogi Research Site

Eugene, Oregon, United States

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Shionogi Research Site

Philadelphia, Pennsylvania, United States

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Shionogi Research Site

Greer, South Carolina, United States

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Shionogi Research Site

Austin, Texas, United States

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Shionogi Research Site

Dallas, Texas, United States

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Shionogi Research Site

Orem, Utah, United States

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Shionogi Research Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Webster LR, Yamada T, Arjona Ferreira JC. A Phase 2b, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Noncancer Pain. Pain Med. 2017 Dec 1;18(12):2350-2360. doi: 10.1093/pm/pnw325.

Reference Type RESULT
PMID: 28371937 (View on PubMed)

Other Identifiers

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1107V9221

Identifier Type: -

Identifier Source: org_study_id

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