Hallux ValgusPhase 4NCT01190722
A Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain
A Phase 4 study testing etoricoxib and Diclofenac in people with Hallux Valgus and Postoperative Pain, run by Karolinska Institutet.
Trial summary
The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hallux Valgus, Postoperative Pain
- What is being tested?
- etoricoxib and Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2010to 12 Dec 2010
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) physiological class 1-2 patients
- aged 18-65 years
- scheduled for elective hallux valgus surgery in general anesthesia
Who cannot join
- NSAID allergy
- liver disease
- renal disease
- uncontrolled cardiovascular disease
- Lithium therapy
- chronic pain
- regular analgesia use
About this study
Official title: A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain
The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).
Read the detailed description
The aim of the present study is to compare patients' satisfaction with pain medication during the first 7 first postoperative days following elective hallux valgus surgery in general anaesthesia between etoricoxib and diclofenac in a prospective randomised double-blind study design.
- Conditions
- Hallux Valgus, Postoperative Pain
- Being tested
- etoricoxib, Diclofenac
- Keywords
- Day case surgery, postoperative pain, NSAIDs, Coxibs
- Medical subject headings
- Hallux Valgus, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxibDrug
120 mg once daily for the 1st 6 postoperative days
DiclofenacDrug
50 mg oral 3 times daily the 1st 6 postoperative days
| Study group | Role | What they receive |
|---|---|---|
| etoricoxib | Experimental | active study drug, coxib Receives: Drug: etoricoxib |
| diclofenac | Active comparator | active traditional NSAID control Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Global Evaluation of Study Medication
Patients self-assessment of global satisfaction with pain medication
Measured: postoperative day 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study start10 Nov 2010
- Primary completion11 Dec 2010
- Study completion12 Dec 2010
Why it stopped: The study site was closed down
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Jakobsson, Karolinska Institutet
- Investigators
- Jan Jakobsson, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190722
- Sponsor's protocol ID
- 201001HV
- Status last verified
- Nov 2017
- First submitted
- 27 Aug 2010
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Etoricoxib and Diclofenac Sodium in Post Hallux Valgus Surgery Pain
- ClinicalTrials.gov ID
- NCT01190722
- Acronym / sponsor ID
- 201001HV
- Conditions
- Hallux Valgus, Postoperative Pain
- Keywords
- Day case surgery, postoperative pain, NSAIDs, Coxibs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study site was closed down
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Nov 2010 (actual)
- Primary completion
- 11 Dec 2010 (actual)
- Study completion
- 12 Dec 2010 (actual)
- First posted
- 30 Aug 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.
The investigators hypothesize that cyclooxygenas-II-selective inhibitors (Coxibs) provide a better patients assessed overall satisfaction when used for pain management after elective hallux valgus surgery as compared to traditional Non-steroidal anti-inflammatory drugs (NSAIDs).
Detailed description
The aim of the present study is to compare patients' satisfaction with pain medication during the first 7 first postoperative days following elective hallux valgus surgery in general anaesthesia between etoricoxib and diclofenac in a prospective randomised double-blind study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etoricoxib | Experimental | Drug: etoricoxibactive study drug, coxib |
| diclofenac | Active comparator | Drug: Diclofenacactive traditional NSAID control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology (ASA) physiological class 1-2 patients
- aged 18-65 years
- scheduled for elective hallux valgus surgery in general anesthesia
Key exclusion criteria (7 listed)
- NSAID allergy
- liver disease
- renal disease
- uncontrolled cardiovascular disease
- Lithium therapy
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 |
|---|---|---|
| etoricoxib120 mg once daily for the 1st 6 postoperative days | Drug | etoricoxib |
| Diclofenac50 mg oral 3 times daily the 1st 6 postoperative days | Drug | diclofenac |
Primary outcome
Patients Global Evaluation of Study Medication
Time frame: postoperative day 1-6
Patients self-assessment of global satisfaction with pain medication
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 2 Dec 2017.
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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.
Jan Jakobsson, Professor principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etoricoxib and Diclofenac in people with Hallux Valgus and Postoperative Pain, run by Karolinska Institutet.
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 3 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 2 Dec 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Patients Global Evaluation of Study Medication (time frame: postoperative day 1-6). 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 2 Dec 2017.