Clinical trial · Observational
A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain
A Post-Marketing Surveillance (PMS) Study on the Safety and Effectiveness of Immediate Release Tapentadol Hydrochloride Among Adult Filipino Patients With Moderate to Severe Acute Non-Cancer Pain
NCT01719601CI-TRIAL-00019219withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
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 immediate release tapentadol hydrochloride for the relief of moderate to severe acute 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 Acute Non-Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Immediate release tapentadol
- description
- Patients will be taking immediate release tapentadol hydrochloride as per the product insert approved in Philippines.
- interventionNames
- 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
- 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 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.