Phase 3
Completed N=1,189
Efficacy and Safety Study of NKTR-181 in Opioid-Naive Subjects With Low Back Pain
Source: ClinicalTrials.gov NCT02362672 ↗Enrolled (actual)
1,189
Serious AEs
1.1%
Results posted
Sep 2020
Primary outcomePrimary: The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline) — 0.9; 1.5 units on a scale — p=0.0019
◆ Published Evidence
Established
29citations · ~4 / year
SUMMIT-07: a randomized trial of NKTR-181, a new molecular entity, full mu-opioid receptor agonist for chronic low-back pain.
Summary
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.
Linked Publications
-
SUMMIT-07: a randomized trial of NKTR-181, a new molecular entity, full mu-opioid receptor agonist for chronic low-back pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline) |
0.9; 1.5 | 0.0019 sig |
| SECONDARY Responder Analysis Based on Percent Reduction in Pain Intensity |
220; 172; 158; 114 | — |
| SECONDARY Patient Global Impression of Change (PGIC): Number of Responders |
159; 100 | — |
| SECONDARY Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) |
-16.7; -9.5; -11.6; -6.9; -3.5; -2.2 | — |
| SECONDARY Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) |
0.3; 0.2 | — |
| SECONDARY Change in Roland Morris Disability Questionnaire (RMDQ) |
-4.0; -3.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02362672) and the linked publication. 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. Informational only — not medical advice.