Symptoms and General Pathology

All Conditions

Rare Diseases

Pain

Acute Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Other Dietary Supplements

Benzocaine

Tapentadol

Analgesics, Opioid

Narcotics

Adrenergic Agents

Neurotransmitter Agents

Tannic Acid

Patients will be taking immediate release tapentadol hydrochloride as per the product insert approved in Philippines.

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.

No intervention

Janssen Pharmaceutica Clinical Trial

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.

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.

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

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

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).

Janssen Pharmaceutica

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain	NCT01719601	Moderate to Sev...	No intervention	18 Years -	Janssen Pharmaceutica
A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain	NCT01719601	Moderate to Sev...	No intervention	18 Years -	Janssen Pharmaceutica
A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain	NCT01719601	Moderate to Sev...	No intervention	18 Years -	Janssen Pharmaceutica
A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain	NCT01719601	Moderate to Sev...	No intervention	18 Years -	Janssen Pharmaceutica

Spots Global Cancer Trial Database for immediate release tapentadol hydrochloride