BursitisPhase 3NCT07328022

Efficacy and Safety of Etoricoxib/Betamethasone Combination in Acute Bursitis, Tendinitis and Synovitis

A Phase 3 study testing Fixed Dose Etoricoxib + Betamethasone and Monotherapy Etoricoxib in people with Bursitis and Tendinitis, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Phase III, multicenter, prospective, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of a fixed-dose combination of etoricoxib/betamethasone compared with etoricoxib alone in patients with an acute episode of bursitis, tendinitis, or synovitis affecting the shoulder, elbow, knee, or… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bursitis, Tendinitis, Synovitis
What is being tested?: Fixed Dose Etoricoxib + Betamethasone and Monotherapy Etoricoxib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 1 siteMexico
Study dates: 14 May 2025to 19 Nov 2025
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients willing and able to participate in the study and provide written informed consent.
Male or female.
Age ≥ 18 years at study entry.
Women of childbearing potential who use an acceptable contraceptive method (barrier, oral hormonal, injectable, subdermal), or women who are naturally postmenopausal or surgically sterile.
Clinical diagnosis of an acute episode of tendinitis, bursitis, or synovitis of the shoulder, elbow, knee, or ankle, with onset within 7 days prior to the first dose of study medication.
A score ≥ 40 mm on a 100-mm Visual Analog Scale (VAS) for maximum pain intensity during active movement, as reported by the patient at the time of study inclusion.
In the opinion of the Principal Investigator or treating physician, the participant is an appropriate candidate for treatment with the investigational product.

Who cannot join

Participation in another clinical study involving an investigational treatment, or participation in such a study within 4 weeks prior to study start.
Patients whose participation could be influenced (e.g., employment relationship with the study site or sponsor, vulnerable populations, etc.).
In the investigator's medical judgment, any disease that affects prognosis and prevents outpatient management, including but not limited to: terminal cancer, renal, cardiac, respiratory, or hepatic failure, mental illness, or scheduled surgical procedures or hospitalizations.
History or presence of any disease or condition that, in the investigator's opinion, could pose a risk to the patient or confound the efficacy and safety evaluation of the investigational product, such as significant degenerative disease or an infectious process in the joints of interest.
Fever: axillary temperature > 37.5°C within 2 days prior to or at the time of study inclusion.-
Pregnant or breastfeeding patients.

Show all 19Show fewer

Contraindication to the study medications.
History of allergic reaction to NSAIDs (non-steroidal anti-inflammatory drugs), paracetamol (acetaminophen), or known hypersensitivity to the study medications.
Significant history of gastrointestinal disorders (e.g., gastric ulcer, Crohn's disease, ulcerative colitis, gastrointestinal bleeding, etc.).
History of congestive heart failure (NYHA Class II-IV), established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary revascularization procedures or angioplasty).
Treatment with corticosteroids within 1 month prior to study start.
Treatment with NSAIDs within 48 hours prior to study start, except for cardioprotective-dose aspirin.
Tendinitis or bursitis secondary to a systemic inflammatory disease, or synovitis secondary to hemophilia.
History of harmful alcohol and/or drug use causing adverse health and social effects.
Clinical suspicion of joint infection or another joint disease other than tendinitis, bursitis, or synovitis.
History of chronic hepatic impairment (Child-Pugh A, B, and/or C).
History of acute renal failure or chronic kidney disease (glomerular filtration rate < 30 mL/min/1.73 m²).
Significant history of known coagulation disorders (e.g., von Willebrand disease, hemophilia, vitamin K deficiency, etc.) or use of anticoagulants.
Oncology patients (except basal cell skin cancer or patients with cancer in remission) or patients with severe diseases that, in the investigator's opinion, have a poor prognosis or a life expectancy of less than 1 year, as well as mental illnesses.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Laboratorios Silanes, S.A. de C.V.
Mexico City, Mexico City, 11000

Other trials in Mexico

About this study

Official title: Efficacy and Safety Study of the Etoricoxib/Betamethasone Combination Compared With Etoricoxib for the Treatment of Patients Diagnosed With an Acute Episode of Bursitis, Tendinitis, or Synovitis of the Shoulder, Elbow, Knee, or Ankle

Read the detailed description

This is a Phase III, multicenter, prospective, randomized, double-blind, parallel-group study to compare the efficacy and safety of a fixed-dose combination of etoricoxib/betamethasone versus etoricoxib alone in patients with an acute episode of bursitis, tendinitis, or synovitis of the shoulder, elbow, knee, or ankle. Eligible participants will be randomized to receive either etoricoxib/betamethasone 90 mg/0.25 mg once daily for 14 days (Group A) or etoricoxib 90 mg once daily for 14 days (Group B). The study includes three visits (Day 1 baseline, Day 7 ± 2, Day 14 ± 2) and two follow-up calls (Day 3 ± 2 and Day 10 ± 2); investigators will collect medical history, perform physical examinations focused on the affected region, and review laboratory and diagnostic assessments as applicable. Pain intensity in the affected joint will be assessed using a Visual Analog Scale (VAS) during active movement and at rest at each visit/call, and daily by patients in a trained Patient Diary completed in the afternoon at the same time each day. Outcomes include changes from baseline in maximum pain (movement and rest) over 14 days, clinical improvement at Days 7 and 14 using the Clinical Global Impression scale, patient and investigator global assessments, and safety based on adverse events summarized by treatment group; rescue medication use (paracetamol 500 mg) and treatment adherence will also be evaluated.

Conditions: Bursitis, Tendinitis, Synovitis
Being tested: Fixed Dose Etoricoxib + Betamethasone, Monotherapy Etoricoxib
Keywords: Bursitis, Tendinitis, Synovitis, Etoricoxib, Betamethasone, Acute Episode
Medical subject headings: Bursitis, Tendinopathy, Synovitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fixed Dose Etoricoxib + BetamethasoneDrug
One tablet of 90 mg / 0.25 mg a day, for 14 days
Monotherapy EtoricoxibDrug
One tablet aog 90 mg a day, for 14 days

Study groups in NCT07328022
Study group	Role	What they receive
Etoricoxib + Betamethasone	Experimental	Administered orally, 1 tablet a day for 14 days. Receives: Drug: Fixed Dose Etoricoxib + Betamethasone
Etoricoxib	Active comparator	Administered orally, 1 tablet a day for 14 days. Receives: Drug: Monotherapy Etoricoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in pain during active movement of the affected joint (VAS 100 mm) at Days 3, 7, 10, and 14 vs baseline, by treatment group.
Pain intensity during active movement will be assessed using a 100-mm Visual Analog Scale (VAS) to determine whether the fixed-dose combination etoricoxib/betamethasone produces a greater reduction in pain compared with etoricoxib alone. Assessments will be obtained at baseline and at follow-up timepoints.
Measured: Baseline and Days 3, 7, 10, and 14
Number of participants with adverse events, and comparison of adverse event frequency and intensity, by treatment group.
Safety will be assessed by comparing adverse events occurring during the study between treatment groups. Adverse events will be summarized using frequencies and percentages and classified according to seriousness/gravity, severity, and causality.
Measured: Up to 14 days

Secondary outcomes (8)

Baseline sociodemographic, anthropometric, biochemical, and clinical characteristics, by treatment group.
Descriptive summary of participant characteristics at baseline by randomized group.
Measured: Baseline
Daily change in maximum pain during active movement of the affected joint (VAS 100 mm) over 14 days vs baseline, by treatment group.
Patients will record daily VAS scores to estimate the magnitude of change from baseline in maximum pain during active movement throughout treatment.
Measured: Daily through Day 14
Daily change in maximum pain at rest of the affected joint (VAS 100 mm) over 14 days vs baseline, by treatment group.
Patients will record daily VAS scores at rest to estimate the magnitude of change from baseline throughout treatment
Measured: Daily through Day 14
Clinical improvement using the Clinical Global Impression (CGI) scale at Days 7 and 14 vs baseline, by treatment group.
Clinical improvement will be evaluated using CGI (severity/improvement categories) at follow-up and compared with baseline by treatment group.
Measured: Baseline, Day 7, and Day 14
Change in Patient Global Assessment of current condition at Days 7 and 14 vs baseline, by treatment group.
The Patient Global Assessment will be recorded and changes from baseline will be described by treatment group.
Measured: Baseline, Day 7, and Day 14
Proportion of patients by category on the Patient Global Assessment at Days 7 and 14 vs baseline, by treatment group.
Changes in the proportion of patients reporting feeling very well, well, fair, poor, or very poor will be summarized by group.
Measured: Baseline, Day 7, and Day 14
Change in Investigator Global Assessment at Days 7 and 14 vs baseline, by treatment group.
The Investigator Global Assessment will be recorded and changes from baseline will be described by treatment group.
Measured: Baseline, Day 7, and Day 14
Proportion of patients by category on the Investigator Global Assessment at Days 7 and 14 vs baseline, by treatment group.
Changes in the proportion of participants classified as very well, well, fair, poor, or very poor by the investigator will be summarized by group.
Measured: Baseline, Day 7, and Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 May 202519 Nov 2025

First posted8 Jan 2026
Study start14 May 2025
Primary completion20 Aug 2025
Study completion19 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for BursitisStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07328022
Sponsor's protocol ID: SIL-30953-III-24(1)
Status last verified: Dec 2025
First submitted: 28 Dec 2025
Last updated: 8 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.
PubMed 9835471
Bertin P, Behier JM, Noel E, Leroux JL. Celecoxib is as efficacious as naproxen in the management of acute shoulder pain. J Int Med Res. 2003 Mar-Apr;31(2):102-12. doi: 10.1177/147323000303100206.
PubMed 12760313
Pincus T, Swearingen CJ, Luta G, Sokka T. Efficacy of prednisone 1-4 mg/day in patients with rheumatoid arthritis: a randomised, double-blind, placebo controlled withdrawal clinical trial. Ann Rheum Dis. 2009 Nov;68(11):1715-20. doi: 10.1136/ard.2008.095539. Epub 2008 Dec 15.
PubMed 19074913
Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728.
PubMed 15370723
Matsumoto AK, Melian A, Mandel DR, McIlwain HH, Borenstein D, Zhao PL, Lines CR, Gertz BJ, Curtis S; Etoricoxib Rheumatoid Arthritis Study Group. A randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis. J Rheumatol. 2002 Aug;29(8):1623-30.
PubMed 12180720
Pisaniello HL, Fisher MC, Farquhar H, Vargas-Santos AB, Hill CL, Stamp LK, Gaffo AL. Efficacy and safety of gout flare prophylaxis and therapy use in people with chronic kidney disease: a Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN)-initiated literature review. Arthritis Res Ther. 2021 Apr 28;23(1):130. doi: 10.1186/s13075-021-02416-y.
PubMed 33910619
(EMA), E.M.A., Guideline on clinical development of fixed combination medicinal products. 2017.
Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clin Ther. 2017 Nov;39(11):2216-2229. doi: 10.1016/j.clinthera.2017.09.011. Epub 2017 Oct 19.
PubMed 29055500
la Torre LF, Franco-Gonzalez DL, Brennan-Bourdon LM, Molina-Frechero N, Alonso-Castro AJ, Isiordia-Espinoza MA. Analgesic Efficacy of Etoricoxib following Third Molar Surgery: A Meta-analysis. Behav Neurol. 2021 Sep 8;2021:9536054. doi: 10.1155/2021/9536054. eCollection 2021.
PubMed 34539935
Watson DJ, Bolognese JA, Yu C, Krupa D, Curtis S. Use of gastroprotective agents and discontinuations due to dyspepsia with the selective cyclooxygenase-2 inhibitor etoricoxib compared with non-selective NSAIDs. Curr Med Res Opin. 2004 Dec;20(12):1899-908. doi: 10.1185/030079904X12681.
PubMed 15701208
Petri M, Hufman SL, Waser G, Cui H, Snabes MC, Verburg KM. Celecoxib effectively treats patients with acute shoulder tendinitis/bursitis. J Rheumatol. 2004 Aug;31(8):1614-20.
PubMed 15290743
Maquirriain J, Kokalj A. Management of acute Achilles tendinopathy: effect of etoricoxib on pain control and leg stiffness. Georgian Med News. 2013 Sep;(222):36-43.
PubMed 24099813
Becker DE. Basic and clinical pharmacology of glucocorticosteroids. Anesth Prog. 2013 Spring;60(1):25-31; quiz 32. doi: 10.2344/0003-3006-60.1.25.
PubMed 23506281
Han, S., Clinical pharmacology review for primary health care providers: II. Steroids. Transl Clin Pharmacol., 2015.
Gómez Valdés, A., Y. Mendoza Cabrera, and L. Escalante Cambeaux, Sinovitis de rodilla, su tratamiento en el área terapéutica de la Facultad de Cultura Física "Nancy Uranga Romagoza". Podium. Revista de Ciencia y Tecnología en la Cultura Física, 2018. 13: p. 274-286.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bursitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Study of the Etoricoxib/Betamethasone Combination Compared With Etoricoxib for the Treatment of Patients Diagnosed With an Acute Episode of Bursitis, Tendinitis, or Synovitis of the Shoulder, Elbow, Knee, or Ankle
ClinicalTrials.gov ID: NCT07328022
Acronym / sponsor ID: SIL-30953-III-24(1)
Conditions: Bursitis, Tendinitis, Synovitis
Keywords: Bursitis, Tendinitis, Synovitis, Etoricoxib, Betamethasone, Acute Episode
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
Study start: 14 May 2025 (actual)
Primary completion: 20 Aug 2025 (actual)
Study completion: 19 Nov 2025 (actual)
First posted: 8 Jan 2026 (actual)
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.

Detailed description

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 + Betamethasone	Experimental	Drug: Fixed Dose Etoricoxib + BetamethasoneAdministered orally, 1 tablet a day for 14 days.
Etoricoxib	Active comparator	Drug: Monotherapy EtoricoxibAdministered orally, 1 tablet a day for 14 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients willing and able to participate in the study and provide written informed consent.
Male or female.
Age ≥ 18 years at study entry.
Women of childbearing potential who use an acceptable contraceptive method (barrier, oral hormonal, injectable, subdermal), or women who are naturally postmenopausal or surgically sterile.
Clinical diagnosis of an acute episode of tendinitis, bursitis, or synovitis of the shoulder, elbow, knee, or ankle, with onset within 7 days prior to the first dose of study medication.

Key exclusion criteria (19 listed)

Participation in another clinical study involving an investigational treatment, or participation in such a study within 4 weeks prior to study start.
Patients whose participation could be influenced (e.g., employment relationship with the study site or sponsor, vulnerable populations, etc.).
In the investigator's medical judgment, any disease that affects prognosis and prevents outpatient management, including but not limited to: terminal cancer, renal, cardiac, respiratory, or hepatic failure, mental illness, or scheduled surgical procedures or hospitalizations.
History or presence of any disease or condition that, in the investigator's opinion, could pose a risk to the patient or confound the efficacy and safety evaluation of the investigational product, such as significant degenerative disease or an infectious process in the joints of interest.
Fever: axillary temperature > 37.5°C within 2 days prior to or at the time of study inclusion.-

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
Fixed Dose Etoricoxib + BetamethasoneOne tablet of 90 mg / 0.25 mg a day, for 14 days	Drug	Etoricoxib + Betamethasone
Monotherapy EtoricoxibOne tablet aog 90 mg a day, for 14 days	Drug	Etoricoxib

Primary outcome

Change in pain during active movement of the affected joint (VAS 100 mm) at Days 3, 7, 10, and 14 vs baseline, by treatment group.
Time frame: Baseline and Days 3, 7, 10, and 14
Pain intensity during active movement will be assessed using a 100-mm Visual Analog Scale (VAS) to determine whether the fixed-dose combination etoricoxib/betamethasone produces a greater reduction in pain compared with etoricoxib alone. Assessments will be obtained at baseline and at follow-up timepoints.
Number of participants with adverse events, and comparison of adverse event frequency and intensity, by treatment group.
Time frame: Up to 14 days
Safety will be assessed by comparing adverse events occurring during the study between treatment groups. Adverse events will be summarized using frequencies and percentages and classified according to seriousness/gravity, severity, and causality.

8 secondary outcomes

Baseline sociodemographic, anthropometric, biochemical, and clinical characteristics, by treatment group.
Time frame: Baseline
Daily change in maximum pain during active movement of the affected joint (VAS 100 mm) over 14 days vs baseline, by treatment group.
Time frame: Daily through Day 14
Daily change in maximum pain at rest of the affected joint (VAS 100 mm) over 14 days vs baseline, by treatment group.
Time frame: Daily through Day 14
Clinical improvement using the Clinical Global Impression (CGI) scale at Days 7 and 14 vs baseline, by treatment group.
Time frame: Baseline, Day 7, and Day 14
Change in Patient Global Assessment of current condition at Days 7 and 14 vs baseline, by treatment group.
Time frame: Baseline, Day 7, and Day 14
Proportion of patients by category on the Patient Global Assessment at Days 7 and 14 vs baseline, by treatment group.
Time frame: Baseline, Day 7, and Day 14
Change in Investigator Global Assessment at Days 7 and 14 vs baseline, by treatment group.
Time frame: Baseline, Day 7, and Day 14
Proportion of patients by category on the Investigator Global Assessment at Days 7 and 14 vs baseline, by treatment group.
Time frame: Baseline, Day 7, and Day 14

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 8 Jan 2026.
Background: PubMed 9835471Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.
Background: PubMed 12760313Bertin P, Behier JM, Noel E, Leroux JL. Celecoxib is as efficacious as naproxen in the management of acute shoulder pain. J Int Med Res. 2003 Mar-Apr;31(2):102-12. doi: 10.1177/147323000303100206.
Background: PubMed 19074913Pincus T, Swearingen CJ, Luta G, Sokka T. Efficacy of prednisone 1-4 mg/day in patients with rheumatoid arthritis: a randomised, double-blind, placebo controlled withdrawal clinical trial. Ann Rheum Dis. 2009 Nov;68(11):1715-20. doi: 10.1136/ard.2008.095539. Epub 2008 Dec 15.
Background: PubMed 15370723Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728.
Background: PubMed 12180720Matsumoto AK, Melian A, Mandel DR, McIlwain HH, Borenstein D, Zhao PL, Lines CR, Gertz BJ, Curtis S; Etoricoxib Rheumatoid Arthritis Study Group. A randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis. J Rheumatol. 2002 Aug;29(8):1623-30.
Background: PubMed 33910619Pisaniello HL, Fisher MC, Farquhar H, Vargas-Santos AB, Hill CL, Stamp LK, Gaffo AL. Efficacy and safety of gout flare prophylaxis and therapy use in people with chronic kidney disease: a Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN)-initiated literature review. Arthritis Res Ther. 2021 Apr 28;23(1):130. doi: 10.1186/s13075-021-02416-y.
Background(EMA), E.M.A., Guideline on clinical development of fixed combination medicinal products. 2017.
Background: PubMed 29055500Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clin Ther. 2017 Nov;39(11):2216-2229. doi: 10.1016/j.clinthera.2017.09.011. Epub 2017 Oct 19.
Background: PubMed 34539935la Torre LF, Franco-Gonzalez DL, Brennan-Bourdon LM, Molina-Frechero N, Alonso-Castro AJ, Isiordia-Espinoza MA. Analgesic Efficacy of Etoricoxib following Third Molar Surgery: A Meta-analysis. Behav Neurol. 2021 Sep 8;2021:9536054. doi: 10.1155/2021/9536054. eCollection 2021.
Background: PubMed 15701208Watson DJ, Bolognese JA, Yu C, Krupa D, Curtis S. Use of gastroprotective agents and discontinuations due to dyspepsia with the selective cyclooxygenase-2 inhibitor etoricoxib compared with non-selective NSAIDs. Curr Med Res Opin. 2004 Dec;20(12):1899-908. doi: 10.1185/030079904X12681.
Background: PubMed 15290743Petri M, Hufman SL, Waser G, Cui H, Snabes MC, Verburg KM. Celecoxib effectively treats patients with acute shoulder tendinitis/bursitis. J Rheumatol. 2004 Aug;31(8):1614-20.
Background: PubMed 24099813Maquirriain J, Kokalj A. Management of acute Achilles tendinopathy: effect of etoricoxib on pain control and leg stiffness. Georgian Med News. 2013 Sep;(222):36-43.
Individual participant dataSharing planned: No

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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.

Marco Antonio Cordova Martinez, MD principal investigator

Unidad de Medicina Especializada SMA SC

Pedro Abraham Garza Alvarez, MD principal investigator

IECSI Clinical Research

Juan Luis Torres Mendez, MD principal investigator

Clinical Research Institute S.C.

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 Fixed Dose Etoricoxib + Betamethasone and Monotherapy Etoricoxib in people with Bursitis and Tendinitis, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

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 7 inclusion and 19 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 8 Jan 2026. 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 Mexico. 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?

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?

Change in pain during active movement of the affected joint (VAS 100 mm) at Days 3, 7, 10, and 14 vs baseline, by treatment group. (time frame: Baseline and Days 3, 7, 10, and 14). The study lists 2 primary outcomes in all. 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 NCT07328022, which also lists 19 linked publications.

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 8 Jan 2026.