Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
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| ClinicalTrials.gov Identifier: NCT01965158 |
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Recruitment Status :
Completed
First Posted : October 18, 2013
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Opioid-induced Constipation | Drug: Naldemedine Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 547 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | August 29, 2013 |
| Actual Primary Completion Date : | January 22, 2015 |
| Actual Study Completion Date : | January 22, 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Naldemedine
Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
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Drug: Naldemedine
Naldemedine 0.2 mg tablet taken orally once a day
Other Names:
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Placebo Comparator: Placebo
Participants received matching placebo orally once daily for 12 weeks.
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Drug: Placebo
Placebo tablet taken orally once a day |
- Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response [ Time Frame: 12-week treatment period ]
A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM.
A responder was defined as a participant having 9 or more positive response weeks 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 was defined as ≥ 3 SBMs per week and an increase from baseline of ≥ 1 SBM per week for that week. If a participant had less than 4 days of diary entries for a week, that week was treated as a "non-response" week.
Any participant with insufficient primary endpoint data (data for less than 9 out of 12 weeks of the Treatment Period or less than 3 out of the last 4 weeks of the 12-week Treatment Period) was treated as a non-responder.
- Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week [ Time Frame: Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment) ]
A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.
Baseline was defined as the 14 days in the screening period prior to study drug administration.
- Change From Baseline to Week 1 in the Number of Spontaneous Bowel Movements Per Week [ Time Frame: Baseline and Week 1 ]
A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.
Baseline was defined as the 14 days in the screening period prior to study drug administration.
- Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements Per Week [ Time Frame: Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment) ]A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. A complete spontaneous bowel movement (CSBM) was defined as an SBM which was accompanied by the feeling of complete evacuation.
- Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements With No Straining Per Week [ Time Frame: Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment) ]
A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation.
The severity of straining with each bowel movement was assessed on the following scale: 0=no straining, 1=mild straining, 2=moderate straining, 3=severe straining, 4=very severe straining. SBMs without straining were defined as SBMs with a straining score of 0.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965158
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| Study Director: | Shionogi Clinical Trials Administrator Clinical Support Help Line | Shionogi |
| Responsible Party: | Shionogi |
| ClinicalTrials.gov Identifier: | NCT01965158 |
| Other Study ID Numbers: |
1314V9231 2013-002241-11 ( EudraCT Number ) |
| First Posted: | October 18, 2013 Key Record Dates |
| Results First Posted: | May 30, 2017 |
| Last Update Posted: | May 30, 2017 |
| Last Verified: | April 2016 |
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Opioid-induced Constipation |
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Constipation Opioid-Induced Constipation Signs and Symptoms, Digestive Narcotic-Related Disorders |
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |