A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain
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|ClinicalTrials.gov Identifier: NCT01719588|
Recruitment Status : Withdrawn (The company decided to cancel this study in conformity with PH FDA Circular 2013-004)
First Posted : November 1, 2012
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Moderate to Severe Chronic Non-cancer Pain||Drug: No intervention||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Post-Marketing Surveillance (PMS) Study on the Safety and Effectiveness of Prolonged Release Tapentadol Hydrochloride Among Adult Filipino Patients With Moderate To Severe Chronic Non-Cancer Pain|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2016|
Prolonged release tapentadol
Patients will be taking prolonged release tapentadol hydrochloride as per the product insert approved in Philippines.
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.
Other Name: Nucynta PR
- Number of patients with incidence of adverse events and adverse drug reactions [ Time Frame: From the date of first exposure of patient to the study medication until 30 days after the last dose of the study medication and at anytime the investigator deems it as necessary, as assessed for 3 years ]
- The short form Brief Pain Inventory (BPI) questionnaire scores [ Time Frame: Baseline (Day 1), Day 7, Day 14 and Day 28, Day 56, and Day 84 ]The short form BPI allows patients to rate the severity of their pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) and the degree to which their pain interferes with common dimensions of feeling and function (general activity, walking, work, mood, enjoyment of life, relations with others, and sleep) on a scale of 0 (no interference) to 10 (interferes completely).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719588
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|