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

Completed · Phase 3 · Has a placebo group

Conditions studied: Low Back Pain, Chronic Pain

In brief

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.

Key facts

Study ID

NCT02362672

Run by

Nektar Therapeutics

People needed

1189

Starts

2015-03-11

Expected to finish

2017-02-01

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Investigator Site - Plantation — Plantation, Florida, United States
• Investigator Site - Tampa — Tampa, Florida, United States
• Investigator Site - West Palm Beach — West Palm Beach, Florida, United States
• Investigator Site - Atlanta — Atlanta, Georgia, United States
• Investigator Site - Blue Ridge — Blue Ridge, Georgia, United States
• Investigator Site - Marietta — Marietta, Georgia, United States
• Investigator Site - Norcross — Norcross, Georgia, United States
• Investigator Site - Gurnee — Gurnee, Illinois, United States
• Investigator Site - West Des Moines — West Des Moines, Iowa, United States
• Investigator Site - Wichita — Wichita, Kansas, United States
• Investigator Site - Louisville — Louisville, Kentucky, United States
• Investigator Site - Bossier — Bossier City, Louisiana, United States
• Investigator Site - New Orleans — New Orleans, Louisiana, United States
• Investigator Site - Shreveport — Shreveport, Louisiana, United States
• Investigator Site - Bay City — Bay City, Michigan, United States
• Investigator Site - Saraland — Saraland, Alabama, United States

Full record on ClinicalTrials.gov

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