Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain



Status:Active, not recruiting
Conditions:Back Pain, Back Pain, Chronic Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 75
Updated:4/17/2018
Start Date:March 2015
End Date:March 2018

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A Phase 3 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-cancer Pain

The purpose of this 52-week open label study is to determine the safety of a new opioid
molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic
non-cancer pain.

This is an open-label safety and tolerability study in which approximately 600 subjects will
receive NKTR-181 for up to 52 weeks. Subjects may include newly enrolled subjects and
subjects who have recently completed SUMMIT-07 or SUMMIT-12 studies.

This study will also investigate the pharmacokinetics of NKTR-181 in patients with chronic
low back pain or chronic non-cancer pain.

Inclusion Criteria:

- Male or non-pregnant, non-nursing female aged 18 to 75 years old

- Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at
least three months

- Not experiencing adequate pain relief or have failed previous treatment with
non-opioid analgesics

- Opioid analgesia is necessary

- Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate
equivalents (MSE) per day of opioid analgesics for at least 7 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:

- History of hypersensitivity, intolerance, or allergy to opioids

- Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during
the study period

- Untreated moderate to severe sleep apnea

- Chronic migraines as the primary pain condition

- Cancer related pain
We found this trial at
56
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Arlington, Texas 76012
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Austin, Texas 78731
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Bay City, Michigan 48706
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Beavercreek, Ohio 45432
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Biloxi, Mississippi 39531
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Blue Ridge, Georgia 30513
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1000 Chinaberry Drive
Bossier City, Louisiana 71111
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Cincinnati, Ohio 45219
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Cincinnati, OH
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Cincinnati, Ohio 45246
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Clearwater, Florida 33765
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Columbus, Ohio 43212
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Dakota Dunes, South Dakota 57047
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Duncansville, Pennsylvania 16635
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Fargo, North Dakota 58104
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Fort Lauderdale, Florida 33312
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Fort Myers, Florida 33912
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Greensboro, North Carolina 27410
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Gurnee, Illinois 60031
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Jacksonville, Florida
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Jenkintown, Pennsylvania 19046
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Kenosha, Wisconsin 53142
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Killeen, Texas 76543
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Las Vegas, Nevada 89102
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Las Vegas, Nevada 89119
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Little Rock, Arkansas 72211
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Louisville, Kentucky 40213
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Marietta, Georgia 30060
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Memphis, Tennessee
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Midlothian, Virginia 23114
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New Orleans, Louisiana 70115
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Norcross, Georgia 30092
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Norfolk, Virginia
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Omaha, Nebraska 68134
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Orlando, Florida 32806
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Ormond Beach, Florida 32174
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Phoenix, AZ
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Pinconning, Michigan 48706
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Plantation, Florida 33324
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Rapid City, South Dakota 57702
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Rochester, New York
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Saint Louis, Missouri 63141
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Saint Louis, Missouri 63141
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Salt Lake City, Utah 84124
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San Antonio, Texas 78229
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Saraland, Alabama 36571
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Shreveport, Louisiana
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Stamford, Connecticut 06905
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Tampa, Florida 33603
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Tempe, Arizona 85283
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West Des Moines, Iowa 50265
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West Jordan, Utah 84088
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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
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