Clinical trial NCT01719588: A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Moderate to Severe Chronic Non-cancer Pain
Keywords: Moderate to severe chronic non-cancer pain
Prolonged release tapentadol hydrochloride
Tapentadol PR
Extended release tapentadol hydrochloride
Nucynta PR
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2012-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Filipino patients with moderate to severe chronic non-cancer pain and who are on the approved product label of prolonged release tapentadol hydrochloride

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with incidence of adverse events and adverse drug reactions
timeFrame: 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 outcomes:
measure: The short form Brief Pain Inventory (BPI) questionnaire scores
timeFrame: Baseline (Day 1), Day 7, Day 14 and Day 28, Day 56, and Day 84
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References: