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

Sponsor

Janssen Pharmaceutica (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01719588

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Moderate to Severe Chronic Non-cancer Pain	Drug: No intervention

Detailed Description

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 prolonged release tapentadol hydrochloride with a dosing regimen stipulated in the product insert. As this is an observational study, assessment of patient will be based on the accepted clinical practice in the Philippines. Patients will be monitored at baseline (Day 1) and throughout the 84-day treatment period of prolonged release tapentadol hydrochloride (every 7 days for the first two weeks, and thereafter every 28 days for the next three months) for effectiveness with the help of short form Brief Pain Inventory (BPI) 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 84 days.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 :

Oct 1, 2014

Anticipated Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Nucynta PR

Arm

Intervention/Treatment

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 Names:

Nucynta PR

Outcome Measures

Primary Outcome Measures

Number of patients with incidence of adverse events and adverse drug reactions [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]

Secondary Outcome Measures

The short form Brief Pain Inventory (BPI) questionnaire scores [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Filipino patients with moderate to severe non-cancer pain with an onset of 12 weeks or less from the baseline visit and pain requires Schedule 2 opioid treatment as per assessment of the prescribing physician
Patients who able to independently communicate pain characteristics, understand and complete self administered questionnaires
Medically stable on the basis of routine physical examination, medical history, and vital signs at the time of baseline visit

Exclusion Criteria:

Refuse to protocol-defined use of effective contraception
Pregnant and lactating women
Patients with severe renal and hepatic impairment, significant respiratory depression, acute or severe bronchial asthma or hypercapnia, and having or suspected paralytic ileus
Patients with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic drugs or receiving other mu-opioid receptor agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, and sedatives
Patients who are receiving Monoamine oxidase (MAO) inhibitors or who have taken them within the last 14 days
Patients with documented history of increased intracranial pressure, impaired consciousness, coma and seizure