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



Status:Completed
Conditions:Back Pain, Back Pain, Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 75
Updated:10/4/2018
Start Date:March 11, 2015
End Date:February 2017

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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

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.

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
We found this trial at
54
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Austin, Texas 78731
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Arlington, Texas 76012
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Atlanta, GA
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Bay City, Michigan 48706
1934
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Beavercreek, Ohio 45432
1904
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Biloxi, Mississippi 39531
1710
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Blue Ridge, Georgia 30513
1910
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1000 Chinaberry Drive
Bossier City, Louisiana 71111
1402
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Cincinnati, Ohio 45219
1882
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Cincinnati, Ohio 45246
1882
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Clearwater, Florida 33765
2116
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Columbus, Ohio 43212
1959
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Duncansville, Pennsylvania 16635
2201
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Fargo, North Dakota 58104
1415
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Fort Lauderdale, Florida 33312
2314
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Greensboro, North Carolina 27410
2151
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Gurnee, Illinois 60031
1721
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Jacksonville, Florida
2130
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Jenkintown, Pennsylvania 19046
2376
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Kenosha, Wisconsin 53142
1725
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Killeen, Texas 76543
1196
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Las Vegas, Nevada 89102
214
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Las Vegas, Nevada 89119
212
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Little Rock, Arkansas 72211
1463
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Louisville, Kentucky 40213
1815
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Marietta, Georgia 30060
1908
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Memphis, Tennessee
1586
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Midlothian, Virginia 23114
2257
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New Orleans, Louisiana 70115
1655
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Norcross, Georgia 30092
1924
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Norfolk, Virginia
2338
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Omaha, Nebraska 68134
1301
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Orlando, Florida 32806
2186
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Ormond Beach, Florida 32174
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343
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Phoenix, AZ
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Pinconning, Michigan 48706
1930
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Plantation, Florida 33324
2308
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Rapid City, South Dakota 57702
1049
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Rochester, New York
2245
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Saint Louis, Missouri 63141
1558
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Saint Louis, Missouri 63141
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Salt Lake City, Utah 84124
570
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San Antonio, Texas 78229
1188
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Saraland, Alabama 36571
1753
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Shreveport, Louisiana
1401
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Stamford, Connecticut 06905
2455
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Tampa, Florida 33603
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Tempe, Arizona 85283
353
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West Des Moines, Iowa 50265
1416
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West Jordan, Utah 84088
561
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West Palm Beach, Florida 33409
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Wichita, Kansas 67207
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Williamsville, New York 14221
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Winston-Salem, North Carolina 27103
2122
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