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

NCT02362672 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1189

Last updated 2020-09-16

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-11
Primary Completion
2016-12-31
Completion
2017-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02362672 on ClinicalTrials.gov