Long Term Safety of Naldemedine

A Randomized Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Study to Evaluate the Long-term Safety of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects With Non-malignant Chronic Pain Receiving Opioid Therapy

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

Study Overview

• Status: Completed
• Conditions: Opioid-induced Constipation
• Intervention / Treatment: Drug: Naldemedine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1246
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Shionogi Research Site
  • Bedford Park, Australia
    • Shionogi Research Site
  • Camperdown, Australia
    • Shionogi Research Site
  • Carina Heights, Australia
    • Shionogi Research Site
  • Caulfield South, Australia
    • Shionogi Research Site
  • Malvern East, Australia
    • Shionogi Research Site
  • Nambour, Australia
    • Shionogi Research Site
  • Sherwood, Australia
    • Shionogi Research Site
  • St Leonards, Australia
    • Shionogi Research Site
• Austria
  • Linz, Austria
    • Shionogi Research Site
  • Vienna, Austria
    • Shionogi Research Site
  • Zams, Austria
    • Shionogi Research Site
• Canada
  • London, Canada
    • Shionogi Research Site
  • Mirabel, Canada
    • Shionogi Research Site
  • Sarnia, Canada
    • Shionogi Research Site
  • Sherbrooke, Canada
    • Shionogi Research Site
  • Toronto, Canada
    • Shionogi Research Site
  • Vancouver, Canada
    • Shionogi Research Site
• Czechia
  • Benesov, Czechia
    • Shionogi Research Site
  • Olomouc, Czechia
    • Shionogi Research Site
  • Ostrava, Czechia
    • Shionogi Research Site
  • Pardubice, Czechia
    • Shionogi Research Site
  • Pribram V- Zdabor, Czechia
    • Shionogi Research Site
• Denmark
  • Glostrup, Denmark
    • Shionogi Research Site
  • Hellerup, Denmark
    • Shionogi Research Site
  • Odense, Denmark
    • Shionogi Research Site
• France
  • Soulaine Sur Aubance, France
    • Shionogi Research Site
• Germany
  • Berlin, Germany
    • Shionogi Research Site
  • Dresden, Germany
    • Shionogi Research Site
  • Halle, Germany
    • Shionogi Research Site
  • Hamburg, Germany
    • Shionogi Research Site
  • Hannover, Germany
    • Shionogi Research Site
  • Kassel, Germany
    • Shionogi Research Site
  • Leipzig, Germany
    • Shionogi Research Site
  • Luenen, Germany
    • Shionogi Research Site
  • Mainz, Germany
    • Shionogi Research Site
  • Muenster, Germany
    • Shionogi Research Site
  • Stadtroda, Germany
    • Shionogi Research Site
• Hungary
  • Balatonfuered, Hungary
    • Shionogi Research Site
  • Budapest, Hungary
    • Shionogi Research Site
  • Debrecen, Hungary
    • Shionogi Research Site
  • Hatvan, Hungary
    • Shionogi Research Site
  • Szikszo, Hungary
    • Shionogi Research Site
• Israel
  • Beer Sheva, Israel
    • Shionogi Research Site
  • Haifa, Israel
    • Shionogi Research Site
  • Tel Aviv, Israel
    • Shionogi Research Site
  • Tel Hashomer, Israel
    • Shionogi Research Site
• Italy
  • Asti, Italy
    • Shionogi Research Site
  • Catania, Italy
    • Shionogi Research Site
  • Chieti, Italy
    • Shionogi Research Site
  • Firenze, Italy
    • Shionogi Research Site
  • Napoli, Italy
    • Shionogi Research Site
  • Rionero in Vulture, Italy
    • Shionogi Research Site
  • Roma, Italy
    • Shionogi Research Site
  • Rome, Italy
    • Shionogi Research Site
• Poland
  • Chorzów, Poland
    • Shionogi Research Site
  • Gdańsk, Poland
    • Shionogi Research Site
  • Katowice, Poland
    • Shionogi Research Site
  • Lublin, Poland
    • Shionogi Research Site
• South Africa
  • Alberton, South Africa
    • Shionogi Research Site
  • Lyttelton Centurion, South Africa
    • Shionogi Research Site
  • Muckleneuk Pretoria, South Africa
    • Shionogi Research Site
  • Pretoria West Pretoria, South Africa
    • Shionogi Research Site
  • Worcester, South Africa
    • Shionogi Research Site
• Spain
  • Barcelona, Spain
    • Shionogi Research Site
  • Girona, Spain
    • Shionogi Research Site
  • Sevilla, Spain
    • Shionogi Research Site
• Sweden
  • Skene, Sweden
    • Shionogi Research Site
  • Stockholm, Sweden
    • Shionogi Research Site
• United Kingdom
  • Bath, United Kingdom
    • Shionogi Research Site
  • Belfast, United Kingdom
    • Shionogi Research Site
  • Bexhill On Sea East Sussex, United Kingdom
    • Shionogi Research Site
  • Chesterfield, United Kingdom
    • Shionogi Research Site
  • Chestfield Kent, United Kingdom
    • Shionogi Research Site
  • Daventry Northants, United Kingdom
    • Shionogi Research Site
  • Devon, United Kingdom
    • Shionogi Research Site
  • Epworth Doncaster, United Kingdom
    • Shionogi Research Site
  • Harrogate, United Kingdom
    • Shionogi Research Site
  • Hinckley, United Kingdom
    • Shionogi Research Site
  • Liverpool, United Kingdom
    • Shionogi Research Site
  • Norwich, United Kingdom
    • Shionogi Research Site
  • Oldham, United Kingdom
    • Shionogi Research Site
  • Peterborough, United Kingdom
    • Shionogi Research Site
  • Randalstown, County Antrim, United Kingdom
    • Shionogi Research Site
  • Spiro Close, Pulborough West Sussex, United Kingdom
    • Shionogi Research Site
  • Wellingborough Northamptonshire, United Kingdom
    • Shionogi Research Site
  • York, United Kingdom
    • Shionogi Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Shionogi Research Site
    • Mobile, Alabama, United States
      • Shionogi Research Site
  • Arizona
    • Chandler, Arizona, United States
      • Shionogi Research Site
    • Glendale, Arizona, United States
      • Shionogi Research Site
    • Goodyear, Arizona, United States
      • Shionogi Research Site
    • Mesa, Arizona, United States
      • Shionogi Research Site
    • Phoenix, Arizona, United States
      • Shionogi Research Site
    • Tucson, Arizona, United States
      • Shionogi Research Site
  • California
    • Fountain Valley, California, United States
      • Shionogi Research Site
    • Garden Grove, California, United States
      • Shionogi Research Site
    • Glendale, California, United States
      • Shionogi Research Site
    • Long Beach, California, United States
      • Shionogi Research Site
    • Los Angeles, California, United States
      • Shionogi Research Site
    • Oceanside, California, United States
      • Shionogi Research Site
    • Sacramento, California, United States
      • Shionogi Research Site
    • Santa Ana, California, United States
      • Shionogi Research Site
    • Upland, California, United States
      • Shionogi Research Site
  • Colorado
    • Colorado Springs, Colorado, United States
      • Shionogi Research Site
  • Florida
    • Boynton Beach, Florida, United States
      • Shionogi Research Site
    • Brandon, Florida, United States
      • Shionogi Research Site
    • Brooksville, Florida, United States
      • Shionogi Research Site
    • Clearwater, Florida, United States
      • Shionogi Research Site
    • Fort Myers, Florida, United States
      • Shionogi Research Site
    • Jacksonville, Florida, United States
      • Shionogi Research Site
    • Lake City, Florida, United States
      • Shionogi Research Site
    • Lakeland, Florida, United States
      • Shionogi Research Site
    • Orlando, Florida, United States
      • Shionogi Research Site
    • Saint Petersburg, Florida, United States
      • Shionogi Research Site
    • South Miami, Florida, United States
      • Shionogi Research Site
    • Tampa, Florida, United States
      • Shionogi Research Site
  • Georgia
    • Atlanta, Georgia, United States
      • Shionogi Research Site
    • Blue Ridge, Georgia, United States
      • Shionogi Research Site
    • Decatur, Georgia, United States
      • Shionogi Research Site
    • Savannah, Georgia, United States
      • Shionogi Research Site
  • Idaho
    • Boise, Idaho, United States
      • Shionogi Research Site
  • Illinois
    • Aurora, Illinois, United States
      • Shionogi Research Site
    • Bloomington, Illinois, United States
      • Shionogi Research Site
    • Decatur, Illinois, United States
      • Shionogi Research Site
    • Rockford, Illinois, United States
      • Shionogi Research Site
    • Schaumburg, Illinois, United States
      • Shionogi Research Site
  • Indiana
    • Evansville, Indiana, United States
      • Shionogi Research Site
    • Lafayette, Indiana, United States
      • Shionogi Research Site
    • Valparaiso, Indiana, United States
      • Shionogi Research Site
  • Kansas
    • Augusta, Kansas, United States
      • Shionogi Research Site
    • Newton, Kansas, United States
      • Shionogi Research Site
    • Wichita, Kansas, United States
      • Shionogi Research Site
  • Kentucky
    • Hartford, Kentucky, United States
      • Shionogi Research Site
  • Louisiana
    • Eunice, Louisiana, United States
      • Shionogi Research Site
    • Lake Charles, Louisiana, United States
      • Shionogi Research Site
    • Mandeville, Louisiana, United States
      • Shionogi Research Site
  • Massachusetts
    • Brockton, Massachusetts, United States
      • Shionogi Research Site
    • Fall River, Massachusetts, United States
      • Shionogi Research Site
    • New Bedford, Massachusetts, United States
      • Shionogi Research Site
  • Michigan
    • Rochester, Michigan, United States
      • Shionogi Research Site
    • Saginaw, Michigan, United States
      • Shionogi Research Site
    • Traverse City, Michigan, United States
      • Shionogi Research Site
  • Mississippi
    • Biloxi, Mississippi, United States
      • Shionogi Research Site
  • Nebraska
    • Fremont, Nebraska, United States
      • Shionogi Research Site
    • Omaha, Nebraska, United States
      • Shionogi Research Site
  • Nevada
    • Henderson, Nevada, United States
      • Shionogi Research Site
    • Las Vegas, Nevada, United States
      • Shionogi Research Site
  • New Jersey
    • Trenton, New Jersey, United States
      • Shionogi Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Shionogi Research Site
  • New York
    • New York, New York, United States
      • Shionogi Research Site
  • North Carolina
    • Greensboro, North Carolina, United States
      • Shionogi Research Site
    • Wilmington, North Carolina, United States
      • Shionogi Research Site
    • Winston-Salem, North Carolina, United States
      • Shionogi Research Site
  • Ohio
    • Akron, Ohio, United States
      • Shionogi Research Site
    • Canton, Ohio, United States
      • Shionogi Research Site
    • Columbus, Ohio, United States
      • Shionogi Research Site
    • Groveport, Ohio, United States
      • Shionogi Research Site
    • Kettering, Ohio, United States
      • Shionogi Research Site
    • Lebanon, Ohio, United States
      • Shionogi Research Site
    • Marion, Ohio, United States
      • Shionogi Research Site
    • Munroe Falls, Ohio, United States
      • Shionogi Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Shionogi Research Site
    • Tulsa, Oklahoma, United States
      • Shionogi Research Site
  • Oregon
    • Portland, Oregon, United States
      • Shionogi Research Site
  • Pennsylvania
    • Huntingdon Valley, Pennsylvania, United States
      • Shionogi Research Site
    • Jenkintown, Pennsylvania, United States
      • Shionogi Research Site
    • Lansdale, Pennsylvania, United States
      • Shionogi Research Site
  • South Carolina
    • Charleston, South Carolina, United States
      • Shionogi Research Site
    • Greer, South Carolina, United States
      • Shionogi Research Site
    • Myrtle Beach, South Carolina, United States
      • Shionogi Research Site
    • Summerville, South Carolina, United States
      • Shionogi Research Site
  • Tennessee
    • Bristol, Tennessee, United States
      • Shionogi Research Site
    • Milan, Tennessee, United States
      • Shionogi Research Site
    • Nashville, Tennessee, United States
      • Shionogi Research Site
  • Texas
    • Austin, Texas, United States
      • Shionogi Research Site
    • Dallas, Texas, United States
      • Shionogi Research Site
    • Houston, Texas, United States
      • Shionogi Research Site
    • Hurst, Texas, United States
      • Shionogi Research Site
    • Sugar Land, Texas, United States
      • Shionogi Research Site
  • Utah
    • Bountiful, Utah, United States
      • Shionogi Research Site
    • Salt Lake City, Utah, United States
      • Shionogi Research Site
    • South Ogden, Utah, United States
      • Shionogi Research Site
  • Virginia
    • Richmond, Virginia, United States
      • Shionogi Research Site
  • Washington
    • Bellevue, Washington, United States
      • Shionogi Research Site
    • Edmonds, Washington, United States
      • Shionogi Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Subjects aged 18 to 80 years inclusive at the time of informed consent
2. Subjects must have non-malignant chronic pain treated and must have opioid induced constipation (OIC)
3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
4. Subjects may or may not be on a routine laxative regimen at the time of Screening

Exclusion Criteria

1. Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
2. Evidence of active medical diseases affecting bowel transit
3. History of pelvic disorders that may be a cause of constipation
4. Surgery (except for minor procedures) within 60 days of Screening
5. 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)
6. Subjects who have never taken laxatives for the treatment of OIC
7. Current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naldemedine; Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.	Drug: Naldemedine; Naldemedine 0.2 mg tablet taken orally once a day; Other Names: S-297995; Symproic®
Placebo Comparator: Placebo; Participants received matching placebo tablets orally once daily for 52 weeks.	Drug: Placebo; Placebo tablet taken orally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	A serious adverse event was defined as any adverse event (AE) that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization were considered an SAE when, based upon appropriate medical judgment, they jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Adverse drug reactions (ADRs) were defined as adverse events that were considered by the investigator to be definitely, probably, or possibly related to study drug. Serious ADRs were defined as serious AEs considered by the investigator to be definitely, probably, or possibly related to study drug.	From the first dose of study drug up to 14 days after the last dose of study drug (54 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Number of Bowel Movements Per Week	Participants monitored their bowel movements and completed a daily bowel habits diary the week prior to study visits (i.e. during Weeks 11, 23, 35, and 51).	Baseline and Weeks 12, 24, 36, and 52
Percentage of Participants Meeting Each Criterion of Laxative Use	Participants who were taking stable routine/regular laxatives at Screening were to continue taking the same regimen throughout the study. The percentage of participants meeting each of the criteria below are reported: 1. Participants not on stable laxatives, defined as participants who did not use laxatives from 28 days prior to the Screening Period to the final dose of study drug or who received only rescue laxative. Rescue is defined as any laxative taken for the first time during the Treatment Period. 1a. Out of participants who were not on stable laxatives, participants who received rescue laxatives. 2. Participants on stable laxatives, defined as participants who may have had at least one/any stable laxative use reported from 28 days prior to Screening Period to the final dose of study drug. 2a. Out of participants who were on stable laxatives, participants who received rescue laxatives. 3. Participants who did not meet criteria 1 or 2.	From 28 days prior to screening until the end of the treatment period (total of 56 weeks)
Change From Baseline in the Overall Score for Patient Assessment of Constipation Symptoms	The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The overall score was calculated as the mean of all 12 items and ranges from 0 (best) to 4 (worst). A negative change from baseline value indicates improvement.	Baseline and Weeks 2, 12, 24, 36, and 52
Change From Baseline in the PAC-SYM Abdominal-symptoms Domain Score	The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The abdominal-symptom domain score was calculated as the mean of the following 4 items: abdominal discomfort, abdominal pain, abdominal bloating and stomach cramps. A negative change from baseline value indicates improvement in symptoms.	Baseline and Weeks 2, 12, 24, 36, and 52
Change From Baseline in the PAC-SYM Rectal-symptoms Domain Score	The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The abdominal-symptom domain score was calculated as the mean of the following 3 items: painful bowel movements, rectal burning during or after a bowel movement, and rectal bleeding or tearing during or after a bowel movement. A negative change from baseline value indicates improvement in symptoms.	Baseline and Weeks 2, 12, 24, 36, and 52
Change From Baseline in the PAC-SYM Stool-symptoms Domain Score	The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The stool-symptom domain score was calculated as the mean of the following 5 items: incomplete bowel movements, bowel movements that were too hard, bowel movements that were too small, straining or squeezing to try to pass bowel movements, and false-alarm bowel movements. A negative change from baseline value indicates improvement in symptoms.	Baseline and Weeks 2, 12, 24, 36, and 52
Change From Baseline in the Patient Assessment of Constipation Quality of Life Overall Score	The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks. Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The overall score was calculated as the mean of all 28 item scores. A negative change from baseline value indicates improvement.	Baseline and Weeks 2, 12, 24, 36, and 52
Change From Baseline in the Physical Discomfort Domain of PAC-QOL	The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks. Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The physical discomfort domain consists of 4 questions related to bloating, feeling heavy, how much of the time participants felt any physical discomfort and how much time they felt the need to open their bowel but were not able to. The physical discomfort score was calculated as the mean of the 4 individual scores. A negative change from baseline value indicates improvement.	Baseline and Weeks 2, 12, 24, 36, and 52
Change From Baseline in the Psychosocial Discomfort Domain of PAC-QOL	The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks. Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The psychosocial discomfort domain consists of 8 questions related to participants' embarrassment regarding their constipation and effects of constipation on eating habits and appetite. The psychosocial discomfort score was calculated as the mean of the 8 individual scores. A negative change from baseline value indicates improvement.	Baseline and Weeks 2, 12, 24, 36, and 52
Change From Baseline in the Worries and Concerns Domain of PAC-QOL	The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks. Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The worries and concerns domain consists of 11 questions related to participants' feelings and concerns about their constipation. The worries and concerns domain score was calculated as the mean of the 11 individual scores. A negative change from baseline value indicates improvement.	Baseline and Weeks 2, 12, 24, 36, and 52
Change From Baseline in the Satisfaction Domain of PAC-QOL	The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks. Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The satisfaction domain consists of 5 questions related to participants' feelings of satisfaction with their bowel function. The satisfaction domain score was calculated as the mean of the 5 individual scores. A negative change from baseline value indicates improvement.	Baseline and Weeks 2, 12, 24, 36, and 52
Participant Global Satisfaction	Participants were asked to rate their degree of satisfaction of constipation and abdominal symptoms from the start of study drug dosing to Week 52 (or early termination). Satisfaction was rated based on the following seven grades: Grade 1 = markedly worsened; Grade 2 = moderately worsened; Grade 3 = slightly worsened; Grade 4 = unchanged; Grade 5 = slightly improved; Grade 6 = moderately improved; Grade 7 = markedly improved	Week 52 or early termination visit

Collaborators and Investigators

• Sponsor: Shionogi

Publications and helpful links

General Publications

• Camilleri M, Hale M, Morlion B, Tack J, Webster L, Wild J. Naldemedine Improves Patient-Reported Outcomes of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain in the COMPOSE Phase 3 Studies. J Pain Res. 2021 Jul 16;14:2179-2189. doi: 10.2147/JPR.S282738. eCollection 2021.
• Webster LR, Hale ME, Yamada T, Wild JE. A Renal Impairment Subgroup Analysis of the Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy. J Pain Res. 2020 Mar 24;13:605-612. doi: 10.2147/JPR.S237833. eCollection 2020.
• Wild J, Webster L, Yamada T, Hale M. Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients >/= 65 Years of Age. Drugs Aging. 2020 Apr;37(4):271-279. doi: 10.1007/s40266-020-00753-2.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2013
• Primary Completion (Actual): January 12, 2016
• Study Completion (Actual): January 12, 2016

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Opioid Induced Constipation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Signs and Symptoms, Digestive; Narcotic-Related Disorders; Constipation; Opioid-Induced Constipation
• Other Study ID Numbers: 1326V9235