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

NCT01719601 | Withdrawn

• 3 other identifiers: CR100919R331333PAI4008TAP-C-12-PH-001-V02
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of immediate release tapentadol hydrochloride for the relief of moderate to severe acute non-cancer pain among Filipino patients.

Conditions

Moderate to Severe Acute Non-Cancer Pain

Keywords

Moderate to severe acute non-cancer pain; Immediate release tapentadol hydrochloride; Tapentadol IR; Nucynta IR

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

Study Arms (1)

Immediate release tapentadol

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

Drug: No intervention

Interventions

No intervention DRUG

This is an observational study. Immediate release tapentadol hydrochloride will be administered as per the recommended doses approved in Philippines. The recommended oral starting dose is 25 mg, 50 mg or 100 mg every 4 to 6 hours 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 IR

Immediate release tapentadol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Filipino patients with moderate to severe acute non-cancer pain and who are on the approved product label of Immediate 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 Patient is experiencing either an acute exacerbation of non-cancer pain or pain that has progressed to the point with the duration of at least 7 days and in the prescribing physician's judgment requires treatment with a Schedule II opioid
• 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, and having or suspected paralytic ileus
• Patients with conditions where drugs with mu-opioid receptor agonist activity are contraindicated
• 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

Sponsors & Collaborators

• Janssen Pharmaceutica: lead

Study Officials

• Janssen Pharmaceutica Clinical Trial

  Janssen Pharmaceutica

  STUDY DIRECTOR

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: September 28, 2015

Record last verified: 2015-09