The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo.
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-control treatment of twelve weeks. During the double-blind treatment period, this study will evaluate the analgesic effect of NKTR-181 versus placebo in patients with moderate to severe chronic low back pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,189
NKTR-181 tablets 100-400 mg twice daily (BID)
Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)
The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline)
The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: 12 Weeks of randomized double blinded period
Responder Analysis Based on Percent Reduction in Pain Intensity
A responder is defined by the Sponsor as a randomized subject who completes the double-blind Randomized Treatment Period and experiences improvement in the Week 12 Weekly Pain Score from Screening Pain Score. This includes the proportion of responders with at least 30% and at least 50% reduction in pain intensity.
Time frame: Screening Baseline through Week 12
Patient Global Impression of Change (PGIC): Number of Responders
The PGIC assesses the change in overall status relative to the initiation of the treatment. The scale measures global change of overall status on a 7-point scale (1 = No change (or condition has got worse), 2 = Almost the same, 3 = A little better, 4 = Somewhat better, 5 = Moderately better, 6 = Better, 7 = A great deal better). The proportion of subjects responding " A great deal better " and "better" was summarized by treatment group.
Time frame: Screening Baseline through Week 12
Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)
The MOS Sleep Scale measure sleep parameters contains 12 items. Eleven of them scored using a 5-point response scale and across 5 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). The original survey items are converted to a 0 to 100 range (by Converting 1 to 0, 2 to 25, 3 to 50, 4 to 75, and 5 to 100). Items in each dimension (disturbance, sleep problems index, somnolence, adequacy, respiratory impairments) of sleep are averaged together to create the score for the scale. The range of each sleep dimension is from 0 to 100. Higher score of sleep disturbance, somnolence, sleep indices, and respiratory impairments indicates relatively worse sleep problem, whereas lower scores for sleep adequacy indicate worse sleep problems.
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Investigator Site - Saraland
Saraland, Alabama, United States
Investigator Site - Phoenix
Phoenix, Arizona, United States
Investigator Site - Tempe
Tempe, Arizona, United States
Investigator Site - Little Rock
Little Rock, Arkansas, United States
Investigator Site - Stamford
Stamford, Connecticut, United States
Investigator Site - Clearwater
Clearwater, Florida, United States
Investigator Site - Fort Lauderdale
Fort Lauderdale, Florida, United States
Investigator Site - Jacksonville
Jacksonville, Florida, United States
Investigator Site - Orlando
Orlando, Florida, United States
Investigator Site - Ormond Beach
Ormond Beach, Florida, United States
...and 44 more locations
Time frame: Screening Baseline through Week 12
Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)
The 12 items of the MOS Sleep Scale measure sleep parameters across 6 dimensions of sleep, including disturbance (4 items), sleep problems index (9 items), quantity (1 item), somnolence (3 items), adequacy (2 items), and respiratory impairments (2 items). One of the 12 items, Sleep quantity, records the actual number of hours slept. Reported here is the sleep quantity.
Time frame: Screening Baseline through Week 12
Change in Roland Morris Disability Questionnaire (RMDQ)
The RMDQ contains 24 items that is used to quantify the impact of low back pain on subject's ability to perform daily activities, mood and sleep. The questionnaire consists of 24 statements derived from the Sickness Impact Profile, with the addition of the phrase "because of my back." The questionnaire covers the areas of mobility, self-care, and sleeping. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.
Time frame: Screening Baseline through Week 12