A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain
Information source: Janssen Pharmaceutica
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Moderate to Severe Chronic Non-cancer Pain
Intervention: No intervention (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Janssen Pharmaceutica Official(s) and/or principal investigator(s): Janssen Pharmaceutica Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica
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.
Clinical Details
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 design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of patients with incidence of adverse events and adverse drug reactions
Secondary outcome: The short form Brief Pain Inventory (BPI) questionnaire scores
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: October 2014
Last updated: June 20, 2013
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