Post Operative PainPhase 3NCT01118572
A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients
A Phase 3 study testing YM177 and etodolac in people with Post Operative Pain, run by Astellas Pharma Inc at 8 sites in Japan.
Trial summary
Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- YM177 and etodolac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 616 participants
- Where
- 8 sitesJapan
- Study dates
- Feb 2010to Nov 2010
- 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
- Patients with spontaneous pain within 24 hours postoperatively
- The intensity of the pain:
- 4-categorical assessment: "Moderate pain" or "Severe pain"
- VAS assessment: 45.0 mm or higher
- Patients whose postoperative pain can be managed using an oral NSAID
Who cannot join
- A past history of aspirin-induced asthma
- A past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease
- Patients who undergoes the surgical procedure under general anesthesia
- Patients taking excluded medications
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chūbu
Study site
Chugoku
Study site
Hokkaido
Study site
Kansai
Study site
Kantou
Study site
Kyusyu
Study site
Shikoku
Study site
Tōhoku
About this study
Official title: A Phase III Study of YM177 (Postoperative Pain) -- An Etodolac- and Placebo-controlled, Multicenter, Double-blind, Group Comparison Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients --
Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.
Read the detailed description
To verify the superiority to placebo and the noninferiority to etodolac of YM177 in terms of efficacy assessment in patients with postoperative pain. Also, to compare them in terms of safety assessment.
- Conditions
- Post Operative Pain
- Being tested
- YM177, etodolac, Placebo
- Keywords
- Celecoxib, Celecox, Pain, Surgery, NSAIDs
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM177Drug
Also called Celecoxib, Celecox
oral
etodolacDrug
Also called Osteluc, Hypen
oral
PlaceboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| YM177 group | Experimental | Not described Receives: Drug: YM177 |
| etodolac group | Active comparator | Not described Receives: Drug: etodolac |
| placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient impressions (4-categorical assessments)
Measured: For 2 days
Secondary outcomes (4)
Pain intensity
Measured: For 2 days
Pain intensity difference
Measured: For 2 days
Discontinuation due to insufficient efficacy
Measured: For 2 days
Safety assessed by AE, clinical lab tests and vital signs
Measured: For 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 616 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
- NCT01118572
- Sponsor's protocol ID
- 177-CL-102
- Status last verified
- Oct 2014
- First submitted
- 5 May 2010
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of YM177 (Postoperative Pain) -- An Etodolac- and Placebo-controlled, Multicenter, Double-blind, Group Comparison Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients --
- ClinicalTrials.gov ID
- NCT01118572
- Acronym / sponsor ID
- 177-CL-102
- Conditions
- Post Operative Pain
- Keywords
- Celecoxib, Celecox, Pain, Surgery, NSAIDs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 6 May 2010 (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.
Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.
Detailed description
To verify the superiority to placebo and the noninferiority to etodolac of YM177 in terms of efficacy assessment in patients with postoperative pain. Also, to compare them in terms of safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YM177 group | Experimental | Drug: YM177 |
| etodolac group | Active comparator | Drug: etodolac |
| placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with spontaneous pain within 24 hours postoperatively
- The intensity of the pain:
- Patients whose postoperative pain can be managed using an oral NSAID
Key exclusion criteria (4 listed)
- A past history of aspirin-induced asthma
- A past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease
- Patients who undergoes the surgical procedure under general anesthesia
- Patients taking excluded medications
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 |
|---|---|---|
| YM177Also: Celecoxib, Celecoxoral | Drug | YM177 group |
| etodolacAlso: Osteluc, Hypenoral | Drug | etodolac group |
| Placebooral | Drug | placebo group |
Primary outcome
Patient impressions (4-categorical assessments)
Time frame: For 2 days
4 secondary outcomes
Pain intensity
Time frame: For 2 days
Pain intensity difference
Time frame: For 2 days
Discontinuation due to insufficient efficacy
Time frame: For 2 days
Safety assessed by AE, clinical lab tests and vital signs
Time frame: For 2 days
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 15 Oct 2014.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YM177 and etodolac in people with Post Operative Pain, run by Astellas Pharma Inc at 8 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 5 inclusion and 4 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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?
Patient impressions (4-categorical assessments) (time frame: For 2 days). 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 15 Oct 2014.