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

Completed · Phase 3

Conditions studied: Low Back Pain, Chronic Pain

In brief

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

Key facts

Study ID

NCT02367820

Run by

Nektar Therapeutics

People needed

638

Starts

2015-04-14

Expected to finish

2018-01-01

Last updated by the study team

2021-06-22

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 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

You may not qualify if…

• 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

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 - Fort Myers — Fort Myers, 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 - Saraland — Saraland, Alabama, United States

Full record on ClinicalTrials.gov

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