Conditions: Low Back Pain Chronic Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1189
Healthy volunteers: no

Brief 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.

Arms:
arm 1: NKTR-181 twice daily (BID) tablets arm 2: Placebo to match NKTR-181 twice daily (BID) tablets

Interventions: intervention 1: NKTR-181 BID tablets intervention 2: Placebo to match NKTR-181 BID tablets
Intervention descriptions: intervention 1: NKTR-181 tablets 100-400 mg twice daily (BID) intervention 2: Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)

Protocol document: