Phase 3
N=638
Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
Low Back Pain · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02367820 ↗Enrolled (actual)
638
Serious AEs
4.7%
Results posted
Oct 2020
Primary outcome: Primary: Number of Participants Reporting Adverse Events — 138; 151; 110; 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NKTR-181 BID tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nektar Therapeutics
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Adverse Events |
138; 151; 110; 62 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52 |
3.57; 4.11; 5.91; 6.18; -1.22; -1.71 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52 |
2.91; 3.25; 5.41; 5.44; -1.23; -1.52 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02367820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.