A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain
|ClinicalTrials.gov Identifier: NCT01719601|
Recruitment Status : Withdrawn (The company decided to cancel this study in conformity with PH FDA Circular 2013-004)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 : September 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Moderate to Severe Acute 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 Immediate Release Tapentadol Hydrochloride Among Adult Filipino Patients With Moderate to Severe Acute Non-Cancer Pain|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2016|
Immediate release tapentadol
Patients will be taking immediate release tapentadol hydrochloride as per the product insert approved in Philippines.
Drug: No intervention
This is an observational study. Immediate release tapentadol hydrochloride will be administered as per the recommended doses approved in Philippines. The recommended oral starting dose is 25 mg, 50 mg or 100 mg every 4 to 6 hours 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 IR
- 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 ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719601
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|