- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362672
Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain (SUMMIT-07)
A Phase 3 Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NKTR-181 in Opioid-Naive Subjects With Moderate to Severe Chronic Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Saraland, Alabama, United States, 36571
- Investigator Site - Saraland
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Arizona
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Phoenix, Arizona, United States, 85023
- Investigator Site - Phoenix
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Tempe, Arizona, United States, 85283
- Investigator Site - Tempe
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Investigator Site - Little Rock
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Connecticut
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Stamford, Connecticut, United States, 06905
- Investigator Site - Stamford
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Florida
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Clearwater, Florida, United States, 33765
- Investigator Site - Clearwater
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Fort Lauderdale, Florida, United States, 33312
- Investigator Site - Fort Lauderdale
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Jacksonville, Florida, United States, 32257
- Investigator Site - Jacksonville
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Orlando, Florida, United States, 32806
- Investigator Site - Orlando
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Ormond Beach, Florida, United States, 32174
- Investigator Site - Ormond Beach
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Plantation, Florida, United States, 33324
- Investigator Site - Plantation
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Tampa, Florida, United States, 33603
- Investigator Site - Tampa
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West Palm Beach, Florida, United States, 33409
- Investigator Site - West Palm Beach
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Georgia
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Atlanta, Georgia, United States, 30338
- Investigator Site - Atlanta
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Blue Ridge, Georgia, United States, 30513
- Investigator Site - Blue Ridge
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Marietta, Georgia, United States, 30060
- Investigator Site - Marietta
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Norcross, Georgia, United States, 30092
- Investigator Site - Norcross
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Illinois
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Gurnee, Illinois, United States, 60031
- Investigator Site - Gurnee
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Iowa
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West Des Moines, Iowa, United States, 50265
- Investigator Site - West Des Moines
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Kansas
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Wichita, Kansas, United States, 67207
- Investigator Site - Wichita
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Kentucky
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Louisville, Kentucky, United States, 40213
- Investigator Site - Louisville
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Louisiana
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Bossier City, Louisiana, United States, 71111
- Investigator Site - Bossier
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New Orleans, Louisiana, United States, 70115
- Investigator Site - New Orleans
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Shreveport, Louisiana, United States, 71105
- Investigator Site - Shreveport
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Michigan
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Bay City, Michigan, United States, 48706
- Investigator Site - Bay City
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Pinconning, Michigan, United States, 48706
- Investigator Site - Pinconning
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Mississippi
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Biloxi, Mississippi, United States, 39531
- Investigator Site - Biloxi
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Missouri
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Saint Louis, Missouri, United States, 63141
- Investigator Site - Saint Louis 1
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Saint Louis, Missouri, United States, 63141
- Investigator Site - Saint Louis 2
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Nebraska
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Omaha, Nebraska, United States, 68134
- Investigator Site - Omaha
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Nevada
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Las Vegas, Nevada, United States, 89102
- Investigator Site - Las Vegas 2
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Las Vegas, Nevada, United States, 89119
- Investigator Site - Las Vegas 1
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New York
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Rochester, New York, United States, 14642
- Investigator Site - Rochester
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Williamsville, New York, United States, 14221
- Investigator Site - Williamsville
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North Carolina
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Greensboro, North Carolina, United States, 27410
- Investigator Site - Greensboro
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Winston-Salem, North Carolina, United States, 27103
- Investigator Site - Winston Salem
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North Dakota
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Fargo, North Dakota, United States, 58104
- Investigator Site - Fargo
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Ohio
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Beavercreek, Ohio, United States, 45432
- Investigator Site - Beavercreek
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Cincinnati, Ohio, United States, 45219
- Investigator Site - Cincinnati 1
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Cincinnati, Ohio, United States, 45246
- Investigator Site - Cincinnati 2
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Columbus, Ohio, United States, 43235
- Investigator Site - Columbus
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Investigator Site - Duncansville
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Jenkintown, Pennsylvania, United States, 19046
- Investigator Site - Jenkintown
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South Dakota
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Rapid City, South Dakota, United States, 57702
- Investigator Site - Rapid City
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Tennessee
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Memphis, Tennessee, United States, 38119
- Investigator Site - Memphis
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Texas
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Arlington, Texas, United States, 76012
- Investigator Site - Arlington
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Austin, Texas, United States, 78731
- Investigator Site - Austin
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Killeen, Texas, United States, 76543
- Investigator Site - Killeen
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San Antonio, Texas, United States, 78229
- Investigator Site - San Antonio
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Utah
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Salt Lake City, Utah, United States, 84124
- Investigator Site - Salt Lake City
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West Jordan, Utah, United States, 84088
- Investigator Site - West Jordan
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Virginia
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Midlothian, Virginia, United States, 23114
- Investigator Site - Midlothian
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Norfolk, Virginia, United States, 23507
- Investigator Site - Norfolk
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Wisconsin
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Kenosha, Wisconsin, United States, 53142
- Investigator Site - Kenosha
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: NKTR-181
NKTR-181 twice daily (BID) tablets
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NKTR-181 tablets 100-400 mg twice daily (BID)
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Placebo Comparator: Placebo
Placebo to match NKTR-181 twice daily (BID) tablets
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Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
Time Frame: 12 Weeks of randomized double blinded period
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The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
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12 Weeks of randomized double blinded period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Responder Analysis Based on Percent Reduction in Pain Intensity
Time Frame: Screening Baseline through Week 12
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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.
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Screening Baseline through Week 12
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Patient Global Impression of Change (PGIC): Number of Responders
Time Frame: Screening Baseline through Week 12
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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.
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Screening Baseline through Week 12
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Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)
Time Frame: Screening Baseline through Week 12
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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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Screening Baseline through Week 12
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Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)
Time Frame: Screening Baseline through Week 12
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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.
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Screening Baseline through Week 12
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Change in Roland Morris Disability Questionnaire (RMDQ)
Time Frame: Screening Baseline through Week 12
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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. |
Screening Baseline through Week 12
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-181-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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