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A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain

NCT01719588 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2015-12-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of prolonged release tapentadol hydrochloride for the relief of moderate to severe chronic non-cancer pain among Filipino patients.

Conditions

  • Moderate to Severe Chronic Non-cancer Pain

Interventions

DRUG

No intervention

This is an observational study. Prolonged release tapentadol hydrochloride will be administered as per the recommended doses approved in Philippines. The recommended oral starting dose is 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg every 12 hours, with or without food depending on the initial pain intensity and thereafter, the dose will be adjusted to maintain adequate analgesia with acceptable tolerability. The dosing regimen will be individualized according to the severity of pain being treated, the previous treatment experience, and the ability to monitor patients.

Sponsors & Collaborators

  • Janssen Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica Clinical Trial · Janssen Pharmaceutica

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-11-30
Completion
2016-11-30

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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 NCT01719588 on ClinicalTrials.gov