Moderate to Severe Acute Non-Cancer PainNCT01719601
A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain
An observational study of Moderate to Severe Acute Non-Cancer Pain, run by Janssen Pharmaceutica.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Acute Non-Cancer Pain
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
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.
Read the 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 immediate release tapentadol hydrochloride with a dosing regimen stipulated in the product insert. As this is an observational study, assessment of patients will be based on the accepted clinical practice in the Philippines. Patients will be monitored at baseline (Day 1) and throughout the 28-day treatment period of tapentadol IR (Day 7, Day 14 and Day 28) for effectiveness with the help of short form Brief Pain Inventory 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 28 days.
- Conditions
- Moderate to Severe Acute Non-Cancer Pain
- Being tested
- No intervention
- Keywords
- Moderate to severe acute non-cancer pain, Immediate release tapentadol hydrochloride, Tapentadol IR, Nucynta IR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
Also called Nucynta IR
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate release tapentadol | Patients will be taking immediate release tapentadol hydrochloride as per the product insert approved in Philippines. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with incidence of adverse events and adverse drug reactions
Measured: 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
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).
Measured: Baseline (Day 1), Day 7, Day 14 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Why it stopped: The company decided to cancel this study in conformity with PH FDA Circular 2013-004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Acute Non-Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica Clinical Trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719601
- Sponsor's protocol ID
- CR100919
- Other IDs
- R331333PAI4008, TAP-C-12-PH-001-V02
- Status last verified
- Sep 2015
- First submitted
- 30 Oct 2012
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01719601
- Acronym / sponsor ID
- CR100919
- Conditions
- Moderate to Severe Acute Non-Cancer Pain
- Keywords
- Moderate to severe acute non-cancer pain, Immediate release tapentadol hydrochloride, Tapentadol IR, Nucynta IR
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The company decided to cancel this study in conformity with PH FDA Circular 2013-004
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 immediate release tapentadol hydrochloride with a dosing regimen stipulated in the product insert. As this is an observational study, assessment of patients will be based on the accepted clinical practice in the Philippines. Patients will be monitored at baseline (Day 1) and throughout the 28-day treatment period of tapentadol IR (Day 7, Day 14 and Day 28) for effectiveness with the help of short form Brief Pain Inventory 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 28 days.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immediate release tapentadol | – | Drug: No interventionPatients will be taking immediate release tapentadol hydrochloride as per the product insert approved in Philippines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAlso: Nucynta IRThis 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. | Drug | Immediate release tapentadol |
Primary outcome
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
1 secondary outcome
The short form Brief Pain Inventory (BPI) questionnaire scores
Time frame: Baseline (Day 1), Day 7, Day 14 and Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica Clinical Trial study director
Janssen Pharmaceutica
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate to Severe Acute Non-Cancer Pain, run by Janssen Pharmaceutica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.