Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain
CompletedPhase 3NCT02362672
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Interventions
- Drug: NKTR-181 BID tablets
- Drug: Placebo to match NKTR-181 BID tablets
- Sponsor
- Nektar Therapeutics
- Start date
- 2015-03-11
- Primary completion
- 2016-12
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 54
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02362672