Acute Toothache Patients Above Moderate Pain After Teeth Extraction SurgeryPhase 3NCT01920386
Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
A Phase 3 study testing Tramadol hydrochloride/Acetaminophen Tab. and Tramadol hydrochloride/Acetaminophen SR Tab. in people with Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. \& Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery
- What is being tested?
- Tramadol hydrochloride/Acetaminophen Tab. and Tramadol hydrochloride/Acetaminophen SR Tab.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Sep 2013
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males/Females aged over 20 years
- Patients with over 2 impacted wisdom teeth in the upper and lower jaws
- Pain VAS Value over 50 mm evaluated as 100mm VAS
- Subjects who voluntarily or legal guardian agreed with written consent
Who cannot join
- Patients with severe heart disease, uncontrol hypertension, diabetes
- Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point
- Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery)
- Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history
- Patients with severe respiratory depression
About this study
Official title: A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. \& Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.
- Being tested
- Tramadol hydrochloride/Acetaminophen Tab., Tramadol hydrochloride/Acetaminophen SR Tab.
- Keywords
- Acute Toothache, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol hydrochloride/Acetaminophen Tab.Drug
Tramadol hydrochloride/Acetaminophen SR Tab.Drug
| Study group | Role | What they receive |
|---|---|---|
| Tramadol hydrochloride/Acetaminophen Tab. | Active comparator | 1tab PO within 5hours from teeth extraction Receives: Drug: Tramadol hydrochloride/Acetaminophen Tab. |
| Tramadol hydrochloride/Acetaminophen SR Tab. | Experimental | 1tab PO within 5hours from teeth extraction and then 1tab more after 6hours Receives: Drug: Tramadol hydrochloride/Acetaminophen SR Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID ; Sum of the pain intensity differences
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Toothache Patients Above Moderate Pain After Teeth Extraction SurgeryStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920386
- Sponsor's protocol ID
- DW 0919 302 Version 1.0
- Status last verified
- Oct 2016
- First submitted
- 8 Aug 2013
- Last updated
- 12 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
- ClinicalTrials.gov ID
- NCT01920386
- Acronym / sponsor ID
- DW 0919 302 Version 1.0
- Keywords
- Acute Toothache, Wontran, Wontran SR Tab., Tramadol Hydrochloride/Acetaminophen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- First posted
- 12 Aug 2013 (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.
A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. \& Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol hydrochloride/Acetaminophen Tab. | Active comparator | Drug: Tramadol hydrochloride/Acetaminophen Tab.1tab PO within 5hours from teeth extraction |
| Tramadol hydrochloride/Acetaminophen SR Tab. | Experimental | Drug: Tramadol hydrochloride/Acetaminophen SR Tab.1tab PO within 5hours from teeth extraction and then 1tab more after 6hours |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult males/Females aged over 20 years
- Patients with over 2 impacted wisdom teeth in the upper and lower jaws
- Pain VAS Value over 50 mm evaluated as 100mm VAS
- Subjects who voluntarily or legal guardian agreed with written consent
Key exclusion criteria (5 listed)
- Patients with severe heart disease, uncontrol hypertension, diabetes
- Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point
- Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery)
- Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history
- Patients with severe respiratory depression
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 |
|---|---|---|
| Tramadol hydrochloride/Acetaminophen Tab. | Drug | Tramadol hydrochloride/Acetaminophen Tab. |
| Tramadol hydrochloride/Acetaminophen SR Tab. | Drug | Tramadol hydrochloride/Acetaminophen SR Tab. |
Primary outcome
SPID ; Sum of the pain intensity differences
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol hydrochloride/Acetaminophen Tab. and Tramadol hydrochloride/Acetaminophen SR Tab. in people with Acute Toothache Patients Above Moderate Pain After Teeth Extraction Surgery, run by Daewon Pharmaceutical Co., Ltd..
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Oct 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SPID ; Sum of the pain intensity differences (time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour). 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 12 Oct 2016.