Clinical trial NCT01719601: A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Moderate to Severe Acute Non-Cancer Pain
Keywords: Moderate to severe acute non-cancer pain
Immediate release tapentadol hydrochloride
Tapentadol IR
Nucynta IR
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 acute non-cancer pain and who are on the approved product label of Immediate release tapentadol hydrochloride

Brief summary: 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.

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 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.

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 Patient is experiencing either an acute exacerbation of non-cancer pain or pain that has progressed to the point with the duration of at least 7 days and in the prescribing physician's judgment requires treatment with a Schedule II opioid
* 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, and having or suspected paralytic ileus
* Patients with conditions where drugs with mu-opioid receptor agonist activity are contraindicated
* 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
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References: