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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
652
Response (Responder/Non-responder) to Study Drug During Weeks 1 to 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.
Time frame: 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
Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.
Time frame: 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
Time frame: 12 weeks
Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12
Time frame: 12 weeks
Change From Baseline in Degree of Straining
A single-item straining question was asked via the eDiary: "How much did you strain during your bowel movement?" Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement.
Time frame: Baseline (Week 1) to end of treatment (Week 12)
Change From Baseline in Stool Consistency (Bristol Stool Scale)
Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.
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Research Site
Birmingham, Alabama, United States
Research Site
Calera, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
Mesa, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Hot Springs, Arkansas, United States
Research Site
Malvern, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Beverly Hills, California, United States
...and 107 more locations
Time frame: Baseline (Week 1) to end of treatment (Week 12)
Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)
A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: "Did you feel like your bowels were completely empty after the bowel movement?" Patients provided a yes or a no response. A positive change from baseline indicates improvement.
Time frame: Baseline (Week 1) to end of treatment (Week 12)
Change From Baseline in Mean Spontaneous Bowel Movements/Week
The number of spontaneous bowel movements/week was determined from the patient's eDiary.
Time frame: 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 in the Laxative Inadequate Response (LIR) Subgroup
Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue - First dose date/time.
Time frame: Baseline (Week 1) to end of treatment (Week 12)
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.
Time frame: Baseline (Week 1) to end of treatment (Week 12)
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain
The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.
Time frame: Baseline (Week 1) to end of treatment (Week 12)