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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01719588
Recruitment Status : Withdrawn (The company decided to cancel this study in conformity with PH FDA Circular 2013-004)
First Posted : November 1, 2012
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):
Janssen Pharmaceutica

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.

Condition or disease Intervention/treatment
Moderate to Severe Chronic Non-cancer Pain Drug: No intervention

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.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : October 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Prolonged release tapentadol
Patients will be taking prolonged release tapentadol hydrochloride as per the product insert approved in Philippines.
Drug: No intervention
This is an observational study. Prolonged release tapentadol hydrochloride will be administered as per the recommended doses approved in Philippines. The recommended oral starting dose is 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg every 12 hours, with or without food depending on the initial pain intensity and thereafter, the dose will be adjusted to maintain adequate analgesia with acceptable tolerability. The dosing regimen will be individualized according to the severity of pain being treated, the previous treatment experience, and the ability to monitor patients.
Other Name: Nucynta PR

Primary Outcome Measures :
  1. Number of patients with incidence of adverse events and adverse drug reactions [ Time Frame: 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 Outcome Measures :
  1. The short form Brief Pain Inventory (BPI) questionnaire scores [ Time Frame: Baseline (Day 1), Day 7, Day 14 and Day 28, Day 56, and Day 84 ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01719588

Sponsors and Collaborators
Janssen Pharmaceutica
Study Director: Janssen Pharmaceutica Clinical Trial Janssen Pharmaceutica

Responsible Party: Janssen Pharmaceutica Identifier: NCT01719588     History of Changes
Other Study ID Numbers: CR100918
R331333PAI4007 ( Other Identifier: Janssen Pharmaceutica )
TPD-C-12-PH-001-V02 ( Other Identifier: Janssen Pharmaceutica )
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Janssen Pharmaceutica:
Moderate to severe chronic non-cancer pain
Prolonged release tapentadol hydrochloride
Tapentadol PR
Extended release tapentadol hydrochloride
Nucynta PR