NCT02362672

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,189 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-control treatment of twelve weeks. During the double-blind treatment period, this study will evaluate the analgesic effect of NKTR-181 versus placebo in patients with moderate to severe chronic low back pain.

Conditions

• Low Back Pain
• Chronic Pain

Interventions

Type	Name	Description
DRUG	NKTR-181 BID tablets	NKTR-181 tablets 100-400 mg twice daily (BID)
DRUG	Placebo to match NKTR-181 BID tablets	Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)

Timeline

• Start date: 2015-03-11
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2015-02-13
• Last updated: 2020-09-16
• Results posted: 2020-09-16

Locations

54 sites across 1 country: United States