Overview

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

Status:
Withdrawn
Trial end date:
2016-11-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Pharmaceutica
Treatments:
Tapentadol
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