Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain

Phase 3

Completed

Conditions: Chronic Pain
Low Back Pain

Interventions: Drug: Placebo to match NKTR-181 BID tablets
Drug: NKTR-181 BID tablets

Registration Number: NCT02362672

Lead Sponsor: Nektar Therapeutics

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1189

Inclusion Criteria

Male or non-pregnant, non-nursing female aged 18 to 75 years old
Clinical diagnosis of moderate to severe, chronic non-neuropathic low back pain for at least six months
Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
Opioid analgesia is necessary
Currently taking no more than 10 mg morphine sulfate equivalents per day of short acting opioids for 14 days prior to entry
Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.
Willing and able to provide informed consent

Exclusion Criteria

Taking extended release or long-acting opioids within 6 months
History of hypersensitivity, intolerance, or allergy to opioids
Compression of spinal nerve root; spinal fracture, tumor, or abscess
Surgical procedures on the low back in the last 12 months or facet nerve root block or radiofrequency ablation in the last 3 months
Untreated moderate to severe sleep apnea

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo to match NKTR-181 BID tablets	Placebo to match NKTR-181 twice daily (BID) tablets
NKTR-181	NKTR-181 BID tablets	NKTR-181 twice daily (BID) tablets

Primary Outcome Measures

Name	Time	Method
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)	12 Weeks of randomized double blinded period	The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

Secondary Outcome Measures

Name	Time	Method
Responder Analysis Based on Percent Reduction in Pain Intensity	Screening Baseline through Week 12	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.
Patient Global Impression of Change (PGIC): Number of Responders	Screening Baseline through Week 12	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.
Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)	Screening Baseline through Week 12	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.
Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)	Screening Baseline through Week 12	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.
Change in Roland Morris Disability Questionnaire (RMDQ)	Screening Baseline through Week 12	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.

Trial Locations

Locations (54): Investigator Site - Little Rock
🇺🇸
Little Rock, Arkansas, United States
Investigator Site - Tempe
🇺🇸
Tempe, Arizona, United States
Investigator Site - Stamford
🇺🇸
Stamford, Connecticut, United States
Investigator Site - Clearwater
🇺🇸
Clearwater, Florida, United States
Investigator Site - Shreveport
🇺🇸
Shreveport, Louisiana, United States
Investigator Site - Greensboro
🇺🇸
Greensboro, North Carolina, United States
Investigator Site - Las Vegas 1
🇺🇸
Las Vegas, Nevada, United States
Investigator Site - Saraland
🇺🇸
Saraland, Alabama, United States
Investigator Site - Atlanta
🇺🇸
Atlanta, Georgia, United States
Investigator Site - Orlando
🇺🇸
Orlando, Florida, United States
Investigator Site - Gurnee
🇺🇸
Gurnee, Illinois, United States
Investigator Site - Pinconning
🇺🇸
Pinconning, Michigan, United States
Investigator Site - Saint Louis 2
🇺🇸
Saint Louis, Missouri, United States
Investigator Site - Winston Salem
🇺🇸
Winston-Salem, North Carolina, United States
Investigator Site - Fargo
🇺🇸
Fargo, North Dakota, United States
Investigator Site - Columbus
🇺🇸
Columbus, Ohio, United States
Investigator Site - Beavercreek
🇺🇸
Beavercreek, Ohio, United States
Investigator Site - Duncansville
🇺🇸
Duncansville, Pennsylvania, United States
Investigator Site - Rapid City
🇺🇸
Rapid City, South Dakota, United States
Investigator Site - Memphis
🇺🇸
Memphis, Tennessee, United States
Investigator Site - West Jordan
🇺🇸
West Jordan, Utah, United States
Investigator Site - Phoenix
🇺🇸
Phoenix, Arizona, United States
Investigator Site - San Antonio
🇺🇸
San Antonio, Texas, United States
Investigator Site - Salt Lake City
🇺🇸
Salt Lake City, Utah, United States
Investigator Site - Omaha
🇺🇸
Omaha, Nebraska, United States
Investigator Site - Fort Lauderdale
🇺🇸
Fort Lauderdale, Florida, United States
Investigator Site - Ormond Beach
🇺🇸
Ormond Beach, Florida, United States
Investigator Site - Marietta
🇺🇸
Marietta, Georgia, United States
Investigator Site - Jacksonville
🇺🇸
Jacksonville, Florida, United States
Investigator Site - Bay City
🇺🇸
Bay City, Michigan, United States
Investigator Site - Tampa
🇺🇸
Tampa, Florida, United States
Investigator Site - Biloxi
🇺🇸
Biloxi, Mississippi, United States
Investigator Site - Wichita
🇺🇸
Wichita, Kansas, United States
Investigator Site - Saint Louis 1
🇺🇸
Saint Louis, Missouri, United States
Investigator Site - Plantation
🇺🇸
Plantation, Florida, United States
Investigator Site - New Orleans
🇺🇸
New Orleans, Louisiana, United States
Investigator Site - Rochester
🇺🇸
Rochester, New York, United States
Investigator Site - Louisville
🇺🇸
Louisville, Kentucky, United States
Investigator Site - West Des Moines
🇺🇸
West Des Moines, Iowa, United States
Investigator Site - Norcross
🇺🇸
Norcross, Georgia, United States
Investigator Site - Austin
🇺🇸
Austin, Texas, United States
Investigator Site - Las Vegas 2
🇺🇸
Las Vegas, Nevada, United States
Investigator Site - Cincinnati 2
🇺🇸
Cincinnati, Ohio, United States
Investigator Site - Bossier
🇺🇸
Bossier City, Louisiana, United States
Investigator Site - Williamsville
🇺🇸
Williamsville, New York, United States
Investigator Site - Killeen
🇺🇸
Killeen, Texas, United States
Investigator Site - Kenosha
🇺🇸
Kenosha, Wisconsin, United States
Investigator Site - Midlothian
🇺🇸
Midlothian, Virginia, United States
Investigator Site - Norfolk
🇺🇸
Norfolk, Virginia, United States
Investigator Site - West Palm Beach
🇺🇸
West Palm Beach, Florida, United States
Investigator Site - Blue Ridge
🇺🇸
Blue Ridge, Georgia, United States
Investigator Site - Cincinnati 1
🇺🇸
Cincinnati, Ohio, United States
Investigator Site - Jenkintown
🇺🇸
Jenkintown, Pennsylvania, United States
Investigator Site - Arlington
🇺🇸
Arlington, Texas, United States

Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts