At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,189 enrolled
Drug / intervention
NKTR-181 BID tablets +1 moredrug
Likely dose
NKTR-181 BID tablets 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating NKTR-181 BID tablets and Placebo to match NKTR-181 BID tablets for Low Back Pain and Chronic Pain. Completed, enrolled 1,189 participants across 54 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain, Chronic Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartMar 2015
Primary CompletionDec 2016
Study CompletionFeb 2017
TodayJul 2026
First PostedFeb 13, 2015
Enrollment StartMar 11, 2015
Primary CompletionDec 1, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.4 years ago
Interventions
NKTR-181 BID tabletsdrug
NKTR-181 tablets 100-400 mg twice daily (BID)
Placebo to match NKTR-181 BID tabletsdrug
Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)