A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain
The purpose of this study is to evaluate the safety and effectiveness of immediate release tapentadol hydrochloride for the relief of moderate to severe acute non-cancer pain among Filipino patients.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- 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 ] [ Designated as safety issue: Yes ]
- The short form Brief Pain Inventory (BPI) questionnaire scores [ Time Frame: Baseline (Day 1), Day 7, Day 14 and Day 28 ] [ Designated as safety issue: No ]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).
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
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
This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes). The study will enroll approximately 100 patients who will be taking immediate release tapentadol hydrochloride with a dosing regimen stipulated in the product insert. As this is an observational study, assessment of patients will be based on the accepted clinical practice in the Philippines. Patients will be monitored at baseline (Day 1) and throughout the 28-day treatment period of tapentadol IR (Day 7, Day 14 and Day 28) for effectiveness with the help of short form Brief Pain Inventory questionnaire. Safety evaluations will include assessment of adverse events, clinical laboratory tests, and co-morbid conditions. The total study will be conducted for 3 years and the duration of treatment will be for 28 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719601
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|