NCT01309841CompletedPhase 3
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 652
- Locations
- 1
- Primary Endpoint
- Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
2
Experimental
Oral treatment
Intervention: NKTR-118 (Drug)
1
Experimental
Oral treatment
Intervention: NKTR-118 (Drug)
3
Placebo Comparator
Oral treatment
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12
Time Frame: Baseline (Week 1) to end of treatment (Week 12)
Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.
Secondary Outcomes
- 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(Baseline (Week 1) to end of treatment (Week 12))
- Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12(12 weeks)
- Change From Baseline in Degree of Straining(Baseline (Week 1) to end of treatment (Week 12))
- Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12(Baseline (Week 1) to end of treatment (Week 12))
- Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours(12 weeks)
- Change From Baseline in Stool Consistency (Bristol Stool Scale)(Baseline (Week 1) to end of treatment (Week 12))
- Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)(Baseline (Week 1) to end of treatment (Week 12))
- Change From Baseline in Mean Spontaneous Bowel Movements/Week(Baseline (Week 1) to end of treatment (Week 12))
- Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)(Baseline (Week 1) to end of treatment (Week 12))
- Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain(Baseline (Week 1) to end of treatment (Week 12))
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced ConstipationOpioid-Induced Constipation (OIC)NCT01323790AstraZeneca700
Completed
Phase 3
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced ConstipationOpioid-Induced Constipation (OIC)NCT01395524AstraZeneca302
Terminated
Phase 3
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related PainOpioid-Induced ConstipationNCT01384292AstraZeneca14
Completed
Phase 1
Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy SubjectsHealthyNCT01318655AstraZeneca50
Completed
Phase 3
Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back PainLow Back PainChronic PainNCT02362672Nektar Therapeutics1,189