Phase 2
N=72
Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
Opioid Induced Bowel Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01122030 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 9; 6; 6; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Naldemedine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shionogi
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
9; 6; 6; 5; 9; 9 | — |
| SECONDARY Change From Baseline to 24 Hours Post-dose in Number of Spontaneous Bowel Movements (SBMs) Per Day |
0.15; 0.20; 0.24; 0.13; 0.17; 0.13 | 0.0767 |
| SECONDARY Change From Baseline to 48 Hours Post-dose in the Number of SBMs Per Day |
0.15; 0.20; 0.24; 0.13; 0.17; 0.13 | 0.8982 |
| SECONDARY Change From Baseline to 24 Hours Post-dose in Number of Bowel Movements (BM) Per Day |
0.35; 0.34; 0.41; 0.35; 0.33; 0.29 | 0.1334 |
| SECONDARY Change From Baseline to 48 Hours Post-dose in Number of Bowel Movements Per Day |
0.35; 0.34; 0.41; 0.35; 0.33; 0.29 | 0.7978 |
| SECONDARY Change From Baseline to 24 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day |
0.03; 0.07; 0.07; 0.06; 0.01; 0.03 | 0.6269 |
| SECONDARY Change From Baseline to 48 Hours Post-dose in Number of Complete Spontaneous Bowel Movements (CSBMs) Per Day |
0.03; 0.07; 0.07; 0.06; 0.01; 0.03 | 0.6131 |
| SECONDARY Time to First Spontaneous Bowel Movement |
27.2; 37.0; 13.9; NA; 4.7; 1.4 | 0.7434 |
| SECONDARY Time to First Bowel Movement |
27.2; 28.4; 13.9; 25.1; 4.7; 1.4 | 0.4923 |
| SECONDARY Time to First Complete Spontaneous Bowel Movement |
NA; NA; NA; NA; NA; 1.7 | 0.1523 |
| SECONDARY Change From Baseline in Straining During Bowel Movements |
2.2; 2.0; 2.2; 1.9; 2.0; 2.5 | — |
| SECONDARY Change From Baseline to 24 Hours Post-dose in Number of Complete Bowel Movements Per Day |
0.13; 0.13; 0.11; 0.14; 0.04; 0.12 | 0.5054 |
| SECONDARY Change From Baseline to 48 Hours Post-dose in Number of Complete Bowel Movements Per Day |
0.13; 0.13; 0.11; 0.14; 0.04; 0.12 | 0.3441 |
| SECONDARY Change From Baseline in Abdominal Bloating |
2.0; 1.4; 1.5; 1.7; 1.7; 2.5 | — |
| SECONDARY Change From Baseline in Abdominal Discomfort |
2.1; 1.5; 2.0; 2.0; 1.9; 2.6 | — |
| SECONDARY Change From Baseline in BM Consistency |
2.9; 3.2; 2.2; 3.0; 3.2; 3.2 | — |
| SECONDARY Change From Baseline in Number of False Start Bowel Movements Per Day |
0.56; 0.67; 0.67; 0.22; 0.56; 0.00 | — |
| SECONDARY Change From Baseline in the Number of Bowel Movements With No Straining Per Day |
0.03; 0.09; 0.05; 0.03; 0.05; 0.03 | — |
| SECONDARY Change From Baseline in Number of Rescue Medications Used Per Day |
0.31; 0.18; 0.36; 0.53; 0.52; 0.28 | — |
| SECONDARY Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score > 8 at Any Time During the Study |
0.0; 0.0; 0.0; 0.0; 0.0; 11.1 | — |
| SECONDARY Percentage of Participants With Webster Opiate Withdrawal Scale (WOWS) Score > 8 at Any Time During the Study |
0.0; 0.0; 0.0; 0.0; 11.1; 0.0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995 |
0.0837; 0.290; 1.00; 3.12; 9.68; 30.9 | — |
| SECONDARY Time to Maximum Observed Plasma Concentration of Naldemedine and Metabolite Nor-S-297995 |
0.75; 1.0; 2.5; 1.0; 1.0; 0.75 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration of Naldemedine and Metabolite Nor-S-297995 |
0.5863; 2.111; 11.71; 31.29; 93.60; 218.2 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Naldemedine and Metabolite Nor-S-297995 |
0.8023; 2.294; 12.04; 31.87; 94.53; 219.9 | — |
| SECONDARY Apparent Elimination Half-life of Naldemedine and Metabolite Nor-S-297995 |
8.13; 7.46; 12.6; 12.2; 10.8; 11.6 | — |
Summary
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
Eligibility Criteria
Inclusion Criteria
- Understand and sign an informed consent form
- Males will agree to use an approved double-barrier method of contraception from Day 1 until 1 month after study completion
- Subject tests negative on urine drug test unless the subject has a prescription for the drug(s) that test positive
Exclusion Criteria
- Subjects under opioid therapy for cancer-related pain or for the management of drug addiction
- Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea, intermittent loose stools, or constipation
- Subjects who have participated in any other investigational drug study within 30 days prior to Day 1
- Prior exposure to S-297995
Data sourced from ClinicalTrials.gov (NCT01122030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.