Clinical trial · Observational

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

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

NCT01719588CI-TRIAL-00020004withdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): The company decided to cancel this study in conformity with PH FDA Circular 2013-004

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Moderate to Severe Chronic Non-cancer Pain	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
No intervention	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Prolonged release tapentadol
description
Patients will be taking prolonged release tapentadol hydrochloride as per the product insert approved in Philippines.
interventionNames
1. Drug: No intervention

Primary outcomes (1)

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 (1)

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
description
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

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.