A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of XXXXX, XXXXX in Patients with Moderate-to-Severe Chronic Low Back Pain

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    Recruiting
Updated on 8 November 2020

Summary

A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of XXXXX, XXXXX in Patients with Moderate-to-Severe Chronic Low Back Pain

Description

To determine the analgesic efficacy of XXXXX (BID) in patients with moderate-to-severe chronic low back pain requiring opioid analgesia for an extended period of time.

Details
Clinical Study IdentifierTX143102
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Between 18 and 75 years of age
Is willing and able to successfully self-administer oral study drug, comply with study restrictions, understand content of study and training material, complete an electronic diary (eDiary) and return for scheduled visits
Has a clinical diagnosis of moderate-to-severe low back pain for ≥6 months
Is opioid naïve or is opioid experienced for management of moderate-to-severe CLBP at least 14 days prior to screening and will continue to require opioid therapy for management of moderate-to-severe CLBP for the duration of the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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