NCT01719588

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
1.9 years until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.1 years

First QC Date

October 30, 2012

Last Update Submit

November 30, 2015

Conditions

Moderate to Severe Chronic Non-cancer Pain

Keywords

Moderate to severe chronic non-cancer painProlonged release tapentadol hydrochlorideTapentadol PRExtended release tapentadol hydrochlorideNucynta PR

Outcome Measures

Primary Outcomes (1)

  • Number of patients with incidence of adverse events and adverse drug reactions

    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)

  • The short form Brief Pain Inventory (BPI) questionnaire scores

    Baseline (Day 1), Day 7, Day 14 and Day 28, Day 56, and Day 84

Study Arms (1)

Prolonged release tapentadol

Patients will be taking prolonged release tapentadol hydrochloride as per the product insert approved in Philippines.

Drug: No intervention

Interventions

No interventionDRUG

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.

Also known as: Nucynta PR
Prolonged release tapentadol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Janssen Pharmaceutica Clinical Trial

    Janssen Pharmaceutica

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 1, 2012

Study Start

October 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 2, 2015

Record last verified: 2015-11