Unilateral Primary Osteoarthritis of KneePhase 3NCT01311804
An Efficacy and Safety Study of Periarticular Parecoxib Sodium for Pain Management in Total Knee Arthroplasty
A Phase 3 study testing parecoxib sodium in people with Unilateral Primary Osteoarthritis of Knee, run by Ministry of Health, Malaysia at 1 site in Malaysia.
Trial summary
Primary Research Objective: The primary objective of this study is to determine efficacy of periarticular parecoxib sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management in total knee arthroplasty Secondary Research Objective: To determine if perioperative use of parecoxib sodium… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Unilateral Primary Osteoarthritis of Knee
- What is being tested?
- parecoxib sodium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteMalaysia
- Study dates
- Apr 2011to Oct 2011
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary knee osteoarthritis on treatment and planned for unilateral total knee arthroplasty and on spinal/general anesthesia
- Subjects age more than 50 and less than 85 years
- Patients with body weight at least 50 kg and not more than 50%above ideal body weight
- Written informed consent obtained from patient or guardian
Who cannot join
- Female patients who are attempting to conceive/pregnant
- Known allergy or hypersensitivity to cocktail regime or to COX-2 inhibitors
- History of bleeding disorders or coagulation defect
- Patients with abnormal liver profile
- Patients with history of stroke or major neurological defect
- Patients with neuropathic pain/sensory disorder
Show all 14Show fewer
- Patients with peptic ulceration or anticoagulant use within 1 month
- History of previous major knee surgery/trauma
- Patients with renal insufficiency
- History of revision total knee arthroplasty
- Patients with knee deformity > 20 degrees
- Patients planned for bilateral knee arthroplasty during the same setting
- Patients with significant bone loss requiring augmentation
- Patients with history of using NSAIDs 24 hours before the surgery
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Tuanku Fauziah
Kangar, Perlis, 01000
Yeap Ewe Juan, +604-976 3333
Yeap Ewe Juan
About this study
Official title: An Open Label,Multicentre, Randomized Trial to Determine the Efficacy of Periarticular Parecoxib Sodium In A Multimodal Cocktail vs Intravenous Parecoxib Sodium for Pain Management in Total Knee Arthroplasty
Primary Research Objective:
The primary objective of this study is to determine efficacy of periarticular parecoxib sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management in total knee arthroplasty
Secondary Research Objective:
- To determine if perioperative use of parecoxib sodium was associated with improved clinical outcomes
- To evaluate the safety, in terms of adverse events; serious adverse events and tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail
Read the detailed description
This is a multi-center, open label, parallel randomized trial designed to evaluate the efficacy and safety of periarticular parecoxib sodium compared to intravenous parecoxib sodium.
125 patients with primary knee osteoarthritis from 4 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then randomly allocated to periarticular parecoxib sodium or intravenous sodium in ratio of 1:1. patients are observed at post-operative 6, 12, 24 hours, subsequently daily for 4 days and finally at 2 week follow-up
- Being tested
- parecoxib sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parecoxib sodiumProcedure or surgery
Also called dynastat
periarticular parecoxib sodium injection will be given during total knee arthroplasty
parecoxib sodiumProcedure or surgery
Also called dynastat
intravenous parecoxib sodium during total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| periarticular parecoxib sodium | Experimental | patients will be given periarticular parecoxib sodium injection Receives: Procedure: parecoxib sodium |
| intravenous parecoxib sodium | Active comparator | intravenous parecoxib sodium will be given during total knee arthroplasty Receives: Procedure: parecoxib sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain control
Post operative pain control( Visual Analogue Scale) with 0 corresponding to "no pain" and 10 to" the worst imaginable pain". Pain will be measured 1st 6 hours, 12 hours, 24 hours and daily for 4 days.
Measured: 4 days
Secondary outcomes (1)
Number and duration of adverse events
- Morphine consumption
- Metochlopromide usage during the 4 days
- Lactulose usage during the 4 days
- Range of motion measured by physiotherapist at 24 hours and daily for 4 days
- time to single leg raise
- time to ambulation
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Primary Osteoarthritis of KneeStudies 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
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Investigators
- Yeap Ewe Juan, Principal investigator, MOH Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311804
- Sponsor's protocol ID
- 02-2010
- Other IDs
- Ministry of Health
- Status last verified
- Mar 2011
- First submitted
- 3 Mar 2011
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label,Multicentre, Randomized Trial to Determine the Efficacy of Periarticular Parecoxib Sodium In A Multimodal Cocktail vs Intravenous Parecoxib Sodium for Pain Management in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01311804
- Acronym / sponsor ID
- 02-2010
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- Apr 2011
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 10 Mar 2011 (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.
Primary Research Objective:
The primary objective of this study is to determine efficacy of periarticular parecoxib sodium in a multimodal cocktail versus intravenous parecoxib injections for pain management in total knee arthroplasty
Secondary Research Objective:
- To determine if perioperative use of parecoxib sodium was associated with improved clinical outcomes
- To evaluate the safety, in terms of adverse events; serious adverse events and tolerability of parecoxib sodium in periarticular injections in a multimodal cocktail
Detailed description
This is a multi-center, open label, parallel randomized trial designed to evaluate the efficacy and safety of periarticular parecoxib sodium compared to intravenous parecoxib sodium.
125 patients with primary knee osteoarthritis from 4 participating sites who meet inclusion/exclusion criteria will be enrolled into the trial. After initial screening, patients will attend clinic for baseline examination. Subjects will then randomly allocated to periarticular parecoxib sodium or intravenous sodium in ratio of 1:1. patients are observed at post-operative 6, 12, 24 hours, subsequently daily for 4 days and finally at 2 week follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| periarticular parecoxib sodium | Experimental | Procedure: parecoxib sodiumpatients will be given periarticular parecoxib sodium injection |
| intravenous parecoxib sodium | Active comparator | Procedure: parecoxib sodiumintravenous parecoxib sodium will be given during total knee arthroplasty |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with primary knee osteoarthritis on treatment and planned for unilateral total knee arthroplasty and on spinal/general anesthesia
- Subjects age more than 50 and less than 85 years
- Patients with body weight at least 50 kg and not more than 50%above ideal body weight
- Written informed consent obtained from patient or guardian
Key exclusion criteria (14 listed)
- Female patients who are attempting to conceive/pregnant
- Known allergy or hypersensitivity to cocktail regime or to COX-2 inhibitors
- History of bleeding disorders or coagulation defect
- Patients with abnormal liver profile
- Patients with history of stroke or major neurological defect
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 |
|---|---|---|
| parecoxib sodiumAlso: dynastatperiarticular parecoxib sodium injection will be given during total knee arthroplasty | Procedure or surgery | periarticular parecoxib sodium |
| parecoxib sodiumAlso: dynastatintravenous parecoxib sodium during total knee arthroplasty | Procedure or surgery | intravenous parecoxib sodium |
Primary outcome
Post operative pain control
Time frame: 4 days
Post operative pain control( Visual Analogue Scale) with 0 corresponding to "no pain" and 10 to" the worst imaginable pain". Pain will be measured 1st 6 hours, 12 hours, 24 hours and daily for 4 days.
1 secondary outcome
Number and duration of adverse events
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
Related trials for Unilateral Primary Osteoarthritis of Knee
Not yet recruiting
Benefits of Early Proprioceptive Re-education Without Visual Information After Total Knee Arthroplasty
Unilateral Primary Osteoarthritis, Left Knee
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.
Yeap Ewe Juan principal investigator
MOH Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing parecoxib sodium in people with Unilateral Primary Osteoarthritis of Knee, run by Ministry of Health, Malaysia at 1 site in Malaysia.
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 14 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: status not confirmed, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanthini Govindasamy (+603-26924249, shanthini@crc.gov.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain control (time frame: 4 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 10 Mar 2011.