SprainPhase 4NCT00954785
Etoricoxib in Acute Ankle Ligament Sprains
A Phase 4 study testing Ankle brace, Diclofenac 50 mg tds and Etoricoxib 120 mg mane in people with Sprain, run by University of Cape Town at 2 sites in South Africa.
Trial summary
The aim of the study is to measure the effectiveness of treatment over 7 days with commonly used anti-inflammatory medications namely etoricoxib and diclofenac (Voltaren) on reducing the severity of pain, swelling and loss of function (range of movement, proprioception) arising from a mild to moderate sprain (partial… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sprain
- What is being tested?
- Ankle brace, Diclofenac 50 mg tds and Etoricoxib 120 mg mane
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Nov 2009to Jul 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 45 years (Rationale: Most injuries occur in this age group, older subjects are more likely to have concomitant pathology e.g. osteoarthrosis)
- Acute lateral ankle ligament sprain less than 48 hours ago (Rationale: It is important to standardize the phase of the injury and enter at the time of the maximum inflammatory response, but this has to be balanced with enough time to allow injured subjects to access the treatment facility, and that all measurements can be completed)
- Grade II ankle sprain injury according to the following: (Rationale: Standard clinical criteria are used to ensure that the severity of injury is similar in all subjects)
- Mild to moderate pain (> 40mm on the VAS)
- Mild to moderate lateral ankle swelling (Greater than 5% increase in ankle volume compared with the uninjured side according to volumetric assessment)
- Tenderness over the anterior talofibular ligament
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- Negative urine and serum pregnancy test (females only) with signed undertaking on use of adequate contraception for the duration of the trial (Rationale: This is to make sure that no pregnant female subjects are entered or can become pregnant during the trial as a safety precaution against drug use in pregnancy)
- No use of analgesics or oral or intramuscular anti-inflammatory drugs in the last 24 hours (Rationale: This is to ensure that at the time of the first assessment, no subject has taken oral or intramuscular medication that may influence the initial assessments of pain and swelling)
- No use of topical anti-inflammatory agents, ice application or compression in the last 12 hours (Rationale: This is to ensure that at the time of the first assessment, no subject has taken topical medication, or used ice or compression that may influence the initial assessments of pain and swelling)
Who cannot join
- Patients with a history of an ankle sprain in the previous 12 months (Rationale: A recent previous injury in the ligaments may affect the healing of a new injury)
- The presence of an ankle fracture as diagnosed on normal radiographs - using the Ottowa ankle rules. (Rationale: This is to ensure that subjects only suffer from a soft tissue injury, so that the study group is homogeneous)
- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid, NSAID's,(including COXIBS) , antipyretics or any of their excipients. (Rationale: This is to ensure that no subject who has a history of hypersensitivity to drugs is given drugs that may cause an allergic reaction)
- Patients who have a sulphonamide allergy. (Rationale: This is to ensure that no subject who has a history of hypersensitivity to certain drugs is given drugs that may cause an allergic reaction)
- Active peptic ulcer within the previous six months (Rationale: It is well established that NSAID's have gastric irritation, gastritis, and ulceration with haemorrhage as possible side effects. This is to ensure that subjects with a history of these syndromes are not included as a safety issue)
- History of recurrent peptic (gastric or duodenal) ulcer (Rationale: It is well established that NSAID's have gastric irritation, gastritis, and ulceration with haemorrhage as possible side effects. This is to ensure that subjects with a history of these syndromes are not included as a safety issue)
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- History of any bleeding disorders, including gastrointestinal bleeding or cerebrovascular bleeding (Rationale: It is well established that non-selective NSAID's can decrease clotting. This is to ensure that subjects with a history of these syndromes are not included as a safety issue)
- Patients with severe congestive heart failure (NYHA 3 - 4) (Rationale: The administration of etoricoxib is contra-indicated in these patients)
- Patients with a medical history of ischemic heart disease or cerebrovascular disease. (Rationale: There is a potential risk of cardiovascular events with COX-2 selective inhibitor use, although this is only documented after long-term use (>18 months).
- History of cardiac failure, left ventricular dysfunction, hypertension or pre-existing oedema. (Rationale: Inhibition of prostaglandin synthesis, as caused by these drugs, may cause fluid retention, oedema and hypertension.
- Patients with peripheral arterial disease (Rationale: Peripheral aerial disease will alter the response to healing in the ankle ligaments)
- Patients with a history or current symptoms and clinical signs of severe impairment of renal function (CrCl <30 ml/min) or moderate to severe impairment of hepatic or function (Rationale: The administration of etoricoxib 120 mg is contra-indicated in these patients)
- Patients with inflammatory bowel disease. (Rationale: The administration of etoricoxib is contra-indicated in these patients).
- Patients consuming more than three alcoholic drinks per day, or patients with a history of alcohol abuse (Rationale: Excessive alcohol intake could negatively affect liver function, interfere with drug metabolism and reduce compliance to the protocol)
- Patients with hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. (Rationale; etoricoxib tablets contain lactose and is therefore contraindicated in these patients)
- Currently pregnant or lactating (Rationale: The administration of etoricoxib is contra-indicated in these patients)
- Woman attempting to conceive. (Rationale: Any drug known to inhibit COX-2 is contra-indicated)
- Concomitant treatment with anti-coagulants (including heparin, warfarin, and ticlopidine) (Rationale: It is well established that NSAID's can decrease clotting. This is to ensure that subjects with a history of established bleeding disorders or those on anti-clotting therapy are not included as a safety issue).
- Concomitant treatment with lithium, methotrexate, angiotensin converting enzyme inhibitors, beta-blockers and diuretics) (Rationale: NSAID's have significant drug interactions with some medications, can potentiate or impair the effects of others and therefore patients on these medications are excluded for safety reasons).
- Concomitant administration of other NSAID's (including aspirin doses > 150 mg) or analgesic agents (Rationale: The purpose of the study is to determine the effects of specific NSAID's on pain and swelling. Concomitant use of other NSAID's will interfere with outcome measures and these patients have to be excluded from the study)
- Concomitant administration of cyclosporine and tacrolimus. (Rationale: Co-administration of these medications with any NSAID's may increase their nephrotoxic effects)
- Concomitant treatment of etoricoxib with rifampicin. (Rationale: Rifampicin is a potent inducer of CYP enzymes and produces a 65% decrease in etoricoxib plasma concentration.)
- Current treatment or treatment within the last two months with corticosteroids (systemic, intra-articular) (Rationale: Long acting corticosteroids can interfere with outcome measures and patients who received these medications have to be excluded from the study)
- Participation in another clinical trial during this study or during the previous month (Rationale: This is to ensure that patients who may still have effects from treatment administered during another trial are not included)
- Inability to comply with the protocol (Rationale: This is to exclude subjects who will not be able to complete the study)
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Kuilsriver Netcare Hospital, 33 Van Riebeeck Road, Kuilsriver
Cape Town, Western Cape, 7580
Sports Medicine Clinic, Sports Science Institute of South Africa
Cape Town, Western Cape, 7700
About this study
Official title: The Efficacy and Safety of Administration of the COX-2 Selective NSAID, Etoricoxib (120mg od. for 7 Days) Compared to Diclofenac (50 mg Tds. for 7 Days) and Placebo as Adjunct Treatment in the First 7 Days of Treatment of Acute Grade II Lateral Ankle Ligaments Sprains: A Clinical Trial
The aim of the study is to measure the effectiveness of treatment over 7 days with commonly used anti-inflammatory medications namely etoricoxib and diclofenac (Voltaren) on reducing the severity of pain, swelling and loss of function (range of movement, proprioception) arising from a mild to moderate sprain (partial tear) of the lateral (outer) ligaments of the ankle joint. This injury is commonly known as an ankle sprain.
- Conditions
- Sprain
- Being tested
- Ankle brace, Diclofenac 50 mg tds, Etoricoxib 120 mg mane
- Keywords
- ankle, ligament, sprain, non-steroidal anti-inflammatory drugs, treatment, Acute ankle ligament sprain
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle braceDevice
Sports Stirrup ankle brace (Aircast)
Diclofenac 50 mg tdsDrug
Also called Voltaren
In the diclofenac group, each subject will receive 50 mg diclofenac in the morning, at mid-day and in the evening
Etoricoxib 120 mg maneDrug
Also called Arcoxia
In the etoricoxib group, each subject will receive 120 mg etoricoxib in the morning, and placebo medication in the evening and at mid-day
| Study group | Role | What they receive |
|---|---|---|
| Placebo drug | Placebo comparator | Not described Receives: Device: Ankle brace |
| Etoricoxib | Experimental | Not described Receives: Device: Ankle brace; Drug: Etoricoxib 120 mg mane |
| Diclofenac | Active comparator | Not described Receives: Device: Ankle brace; Drug: Diclofenac 50 mg tds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Measured: 7 days
Secondary outcomes (4)
Swelling
Measured: 7 days
Range of motion
Measured: 7 days
Proprioception
Measured: 7 days
Adverse events
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: The study was terminated by Merck USA. The company did not supply drugs for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SprainStudies 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 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
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Martin P Schwellnus, MBBCh, MD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954785
- Sponsor's protocol ID
- IISP 34251
- Other IDs
- Rec Ref 005/2008
- Status last verified
- Aug 2009
- First submitted
- 6 Aug 2009
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
PubMed 32797734
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Administration of the COX-2 Selective NSAID, Etoricoxib (120mg od. for 7 Days) Compared to Diclofenac (50 mg Tds. for 7 Days) and Placebo as Adjunct Treatment in the First 7 Days of Treatment of Acute Grade II Lateral Ankle Ligaments Sprains: A Clinical Trial
- ClinicalTrials.gov ID
- NCT00954785
- Acronym / sponsor ID
- IISP 34251
- Conditions
- Sprain
- Keywords
- ankle, ligament, sprain, non-steroidal anti-inflammatory drugs, treatment, Acute ankle ligament sprain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was terminated by Merck USA. The company did not supply drugs for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 7 Aug 2009 (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 aim of the study is to measure the effectiveness of treatment over 7 days with commonly used anti-inflammatory medications namely etoricoxib and diclofenac (Voltaren) on reducing the severity of pain, swelling and loss of function (range of movement, proprioception) arising from a mild to moderate sprain (partial tear) of the lateral (outer) ligaments of the ankle joint. This injury is commonly known as an ankle sprain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo drug | Placebo comparator | Device: Ankle brace |
| Etoricoxib | Experimental | Device: Ankle brace, Drug: Etoricoxib 120 mg mane |
| Diclofenac | Active comparator | Device: Ankle brace, Drug: Diclofenac 50 mg tds |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18 to 45 years (Rationale: Most injuries occur in this age group, older subjects are more likely to have concomitant pathology e.g. osteoarthrosis)
- Acute lateral ankle ligament sprain less than 48 hours ago (Rationale: It is important to standardize the phase of the injury and enter at the time of the maximum inflammatory response, but this has to be balanced with enough time to allow injured subjects to access the treatment facility, and that all measurements can be completed)
- Grade II ankle sprain injury according to the following: (Rationale: Standard clinical criteria are used to ensure that the severity of injury is similar in all subjects)
- Negative urine and serum pregnancy test (females only) with signed undertaking on use of adequate contraception for the duration of the trial (Rationale: This is to make sure that no pregnant female subjects are entered or can become pregnant during the trial as a safety precaution against drug use in pregnancy)
- No use of analgesics or oral or intramuscular anti-inflammatory drugs in the last 24 hours (Rationale: This is to ensure that at the time of the first assessment, no subject has taken oral or intramuscular medication that may influence the initial assessments of pain and swelling)
Key exclusion criteria (25 listed)
- Patients with a history of an ankle sprain in the previous 12 months (Rationale: A recent previous injury in the ligaments may affect the healing of a new injury)
- The presence of an ankle fracture as diagnosed on normal radiographs - using the Ottowa ankle rules. (Rationale: This is to ensure that subjects only suffer from a soft tissue injury, so that the study group is homogeneous)
- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid, NSAID's,(including COXIBS) , antipyretics or any of their excipients. (Rationale: This is to ensure that no subject who has a history of hypersensitivity to drugs is given drugs that may cause an allergic reaction)
- Patients who have a sulphonamide allergy. (Rationale: This is to ensure that no subject who has a history of hypersensitivity to certain drugs is given drugs that may cause an allergic reaction)
- Active peptic ulcer within the previous six months (Rationale: It is well established that NSAID's have gastric irritation, gastritis, and ulceration with haemorrhage as possible side effects. This is to ensure that subjects with a history of these syndromes are not included as a safety issue)
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 |
|---|---|---|
| Ankle braceSports Stirrup ankle brace (Aircast) | Device | Diclofenac, Etoricoxib, Placebo drug |
| Diclofenac 50 mg tdsAlso: VoltarenIn the diclofenac group, each subject will receive 50 mg diclofenac in the morning, at mid-day and in the evening | Drug | Diclofenac |
| Etoricoxib 120 mg maneAlso: ArcoxiaIn the etoricoxib group, each subject will receive 120 mg etoricoxib in the morning, and placebo medication in the evening and at mid-day | Drug | Etoricoxib |
Primary outcome
Pain
Time frame: 7 days
4 secondary outcomes
Swelling
Time frame: 7 days
Range of motion
Time frame: 7 days
Proprioception
Time frame: 7 days
Adverse events
Time frame: 14 days
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 20 Jun 2013.
- Derived from this study: PubMed 32797734Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
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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.
Martin P Schwellnus, MBBCh, MD principal investigator
University of Cape Town
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ankle brace, Diclofenac 50 mg tds and Etoricoxib 120 mg mane in people with Sprain, run by University of Cape Town at 2 sites in South Africa.
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 9 inclusion and 25 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. 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 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?
Pain (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954785, which also lists 1 linked publication.
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 20 Jun 2013.