At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 638 enrolled
Drug / intervention
NKTR-181 BID tabletsdrug
Likely dose
NKTR-181 BID tablets 600 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 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-Cancer Pain
In Brief
A Phase 3 clinical trial evaluating NKTR-181 BID tablets for Low Back Pain and Chronic Pain. Completed, enrolled 638 participants across 56 sites.
Detailed Summary
The purpose of this 52-week open label study is to determine the long-term safety of a new opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain, Chronic Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 2015
Enrollment StartApr 2015
Primary CompletionDec 2017
Study CompletionJan 2018
TodayJul 2026
First PostedFeb 20, 2015
Enrollment StartApr 14, 2015
Primary CompletionDec 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.4 years ago
Interventions
NKTR-181 BID tabletsdrug
NKTR-181 tablets 100-600 mg twice daily (BID)