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

Phase 3 Completed 1189 enrolled Nektar Therapeutics

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2015-03-11
Primary completion: 2016-12
Completion: 2017-02

Outcome

Met primary endpoint

registry analysis (superiority test); NKTR-181 vs Placebo; p = 0.0019; Mean Difference (Net) -0.55; z-test NCT02362672 ↗

release “The clinical trial met the primary efficacy endpoint of the study in demonstrating significantly improved chronic back pain relief with NKTR-181 compared to placebo (p=0.0019).” nektar.com ↗

Publications

Results Markman J, Gudin J, Rauck R, Argoff C, Rowbotham M, Agaiby E, Gimbel J, Katz N, Doberstein SK, Tagliaferri M, Lu L, Siddhanti S, Hale M. SUMMIT-07: a randomized trial of NKTR-181, a new molecular entity, full mu-opioid receptor agonist for chronic low-back pain. Pain. 2019 Jun;160(6):1374-1382. doi: 10.1097/j.pain.0000000000001517.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OXYCODEGOL	Small molecule	100 mg	—
Subject	OXYCODEGOL	Small molecule	400 mg	—