Phase 3
N=652
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Opioid-Induced Constipation (OIC)
Bottom Line
View on ClinicalTrials.gov: NCT01309841 ↗Enrolled (actual)
652
Serious AEs
4.6%
Results posted
Jun 2015
Primary outcome: Primary: Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12 — 87; 95; 63 Number of patients — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NKTR-118 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12 |
87; 95; 63 | 0.015 sig |
| SECONDARY Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12 |
49; 57; 34 | 0.028 sig |
| SECONDARY Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours |
20.4; 5.9; 35.8 | — |
| SECONDARY Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12 |
2.21; 2.48; 1.66 | <0.001 sig |
| SECONDARY Change From Baseline in Degree of Straining |
-0.64; -0.73; -0.54 | 0.176 |
| SECONDARY Change From Baseline in Stool Consistency (Bristol Stool Scale) |
0.53; 0.66; 0.47 | 0.564 |
| SECONDARY Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement) |
22.31; 27.04; 18.45 | 0.094 |
| SECONDARY Change From Baseline in Mean Spontaneous Bowel Movements/Week |
2.56; 3.02; 2.02 | 0.011 sig |
| SECONDARY Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup |
20.6; 5.4; 43.4 | — |
| SECONDARY Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) |
-0.76; -0.81; -0.69; -0.61; -0.65; -0.63 | 0.273 |
| SECONDARY Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain |
-0.91; -1.06; -0.89 | 0.831 |
Summary
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent prior to any study-specific procedures.
- Men and women who are between the ages of ≥18 and <85 years.
- Self-reported active symptoms of OIC at screening (<3 SBMs/week and experiencing ≥1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
- Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
- Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week OIC confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a BM has not occurred within at least 72 hours of the last recorded BM.
Exclusion Criteria
- Patients receiving Opioid regimen for treatment of pain related to cancer.
- History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer.
- Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
- Other issues to the gastrointestinal tract that could impose a risk to the patient.
- Pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT01309841). 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.