Assessment of efficacy and safety in patients with non-cancer-related pain and opioid-induced constipation.
- Conditions
- Opioid-induced constipation (OIC)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-001987-24-SK
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 630
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 opiod 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 530
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Up to 4 weeks;Main Objective: The primary objective of this study is to compare the efficacy of NKTR-118 12.5 and 25 mg with placebo in the treatment of patients who have OIC.;Secondary Objective: The secondary objectives are to compare NKTR-118 12.5 and 25 mg with placebo on the daily signs and symptoms associated with OIC (straining, sensation of incomplete evacuation, and stool consistency), symptoms of constipation and quality of life.;Primary end point(s): Response (responder/non-responder) to study drug during Weeks 1 to 4, where a responder is defined as having at least 3 Spontaneous Bowel Movements (SBMs)/week, with at least 1 SBM/week increase over baseline, for at least 3 out of the first 4 weeks.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Response (responder/non-responder) to study drug in the LIR subgroup during Weeks 1 to 4, where a responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline, for at least 3 out of the first 4 weeks. <br>Response (responder/non-responder) to study drug over the entire 12 week treatment period, where a responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline, for at least 75% of the weeks. <br>Regularity during the first 4 weeks of treatment, where regularity is measured as the mean number of days per week with at least 1 SBM during Weeks 1 to 4.;Timepoint(s) of evaluation of this end point: Up to 4 weeks<br>12 weeks<br>Up to 4 weeks