Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract PainNCT01876121
Celecoxib Japan Observational Study for the Patients With Acute Pain
An observational study of Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain, run by Astellas Pharma Inc at 7 sites in Japan.
Trial summary
This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- How many people
- 784 participants
- Where
- 7 sitesJapan
- Study dates
- Jul 2012to Apr 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with traumatic pain, post-surgical pain and tooth extract pain
Who may be able to join
- Patients with traumatic pain, post-surgical pain and tooth extract pain
Who cannot join
- Hyperreactive to sulfonamide
- Aspirin asthma patients
- Peptidic ulcer patients
- Serious liver disease patients
- Serious kidney disease patients
- Serious heart failure patients
- End of pregnancy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Chūbu
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyushu
Study site
Shikoku
Study site
Tōhoku
About this study
This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.
Read the detailed description
Patients with traumatic pain, post-surgical and tooth extract pain will be included in this study. Patients will receive Celecoxib for 2 weeks and the efficacy on pain relief and the safety will be evaluated.
- Being tested
- Celecoxib
- Keywords
- NSAIDs, Acute pain
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celecox
oral
| Study group | Role | What they receive |
|---|---|---|
| Celecox group | Not described Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by the incidence of adverse events and lab-tests
Measured: For 2 weeks
Secondary outcomes (1)
Overall pain improvement assessed by visual analogue scale (VAS)
Measured: Baseline and week-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJul 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract 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
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876121
- Sponsor's protocol ID
- COX-05
- Status last verified
- Sep 2014
- First submitted
- 10 Jun 2013
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celecoxib Japan Observational Study for the Patients With Acute Pain
- ClinicalTrials.gov ID
- NCT01876121
- Acronym / sponsor ID
- COX-05
- Keywords
- NSAIDs, Acute pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Jun 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.
This study is to assess the safety and efficacy of celecoxib on the pain relief from acute pain.
Detailed description
Patients with traumatic pain, post-surgical and tooth extract pain will be included in this study. Patients will receive Celecoxib for 2 weeks and the efficacy on pain relief and the safety will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecox group | – | Drug: Celecoxib |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with traumatic pain, post-surgical pain and tooth extract pain
Key inclusion criteria (1 listed)
- Patients with traumatic pain, post-surgical pain and tooth extract pain
Key exclusion criteria (7 listed)
- Hyperreactive to sulfonamide
- Aspirin asthma patients
- Peptidic ulcer patients
- Serious liver disease patients
- Serious kidney disease patients
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 |
|---|---|---|
| CelecoxibAlso: Celecoxoral | Drug | Celecox group |
Primary outcome
Safety assessed by the incidence of adverse events and lab-tests
Time frame: For 2 weeks
1 secondary outcome
Overall pain improvement assessed by visual analogue scale (VAS)
Time frame: Baseline and week-2
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 5 Sep 2014.
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.
Use Central Contact study chair
Astellas Pharma Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Traumatic Pain, Post-surgical Pain and Tooth Extract Pain, run by Astellas Pharma Inc at 7 sites in Japan.
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 1 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: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Safety assessed by the incidence of adverse events and lab-tests (time frame: For 2 weeks). 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 5 Sep 2014.