Calcific TendinitisNCT07539961
Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the Shoulder
A study testing Paracetamol + Ibuprofen + Famotidine and Paracetamol + Ibuprofen in people with Calcific Tendinitis, run by University Hospital Dubrava.
Trial summary
This randomized, open-label, single-centre controlled study evaluates the efficacy and safety of combined paracetamol and ibuprofen therapy with versus without famotidine in the treatment of calcific tendinitis of the shoulder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcific Tendinitis
- What is being tested?
- Paracetamol + Ibuprofen + Famotidine and Paracetamol + Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years
- Clinical history of shoulder pain consistent with calcific tendinitis
- Presence of calcifications confirmed by shoulder X-ray
- Ability and willingness to comply with study procedures and follow-up
- Signed informed consent
Who cannot join
- Known allergy or hypersensitivity to paracetamol, ibuprofen, or famotidine
- Active gastrointestinal disease contraindicating NSAID use
- Chronic dual antiplatelet therapy
- Current use of proton pump inhibitors other than pantoprazole (unless temporarily replaced)
- Severe systemic diseases that may interfere with study participation or outcomes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized Controlled Single-Centre Study Evaluating the Efficacy of Therapy With Paracetamol and Ibuprofen, With and Without Famotidine, in the Treatment of Calcific Tendinitis of the Shoulder
This randomized, open-label, single-centre controlled study evaluates the efficacy and safety of combined paracetamol and ibuprofen therapy with versus without famotidine in the treatment of calcific tendinitis of the shoulder. Outcomes include pain reduction, functional improvement, radiological changes, and need for additional interventions over a 12-month follow-up period.
Read the detailed description
Calcific tendinitis of the shoulder is a common cause of acute and chronic shoulder pain, often requiring multimodal treatment. Nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics such as paracetamol are frequently used as first-line therapy; however, gastrointestinal adverse effects remain a concern. Famotidine, a histamine H2 receptor antagonist, may improve gastrointestinal safety and potentially influence treatment tolerability.
This study is a randomized, open-label, single-centre controlled trial conducted in the emergency surgical outpatient setting. The objective is to compare the efficacy and safety of alternating paracetamol and ibuprofen therapy with the addition of famotidine versus the same analgesic regimen without famotidine in patients with calcific tendinitis of the shoulder.
Participants will be randomized into two groups:
Intervention group: alternating paracetamol (1000 mg) and ibuprofen (400 mg) for 14 days with famotidine 40 mg once daily Control group: paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly for 14 days without famotidine Patients on chronic pantoprazole therapy will temporarily switch to famotidine during the intervention period.
The primary outcome is the change in pain and shoulder function measured by the Oxford Shoulder Score (OSS) over 12 months. Secondary outcomes include radiographic changes in calcifications, frequency of additional therapeutic interventions (physical therapy, extracorporeal shockwave therapy, corticosteroid injections, barbotage, and arthroscopic surgery), and treatment safety and tolerability.
Patients will be followed at 2 weeks, 6 weeks, 3 months, and 12 months. Assessments include Visual Analog Scale (VAS), OSS questionnaires, range of motion, and radiographic evaluation at 3 months. Adverse events will be monitored throughout the study.
- Conditions
- Calcific Tendinitis
- Being tested
- Paracetamol + Ibuprofen + Famotidine, Paracetamol + Ibuprofen
- Keywords
- Calcific tendinitis, Shoulder pain, NSAIDs, Famotidine
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol + Ibuprofen + FamotidineDrug
Participants receive alternating doses of paracetamol (1000 mg) and ibuprofen (400 mg) over a 14-day period, together with famotidine 40 mg once daily. Patients on chronic pantoprazole therapy temporarily switch to famotidine during this period.
Paracetamol + IbuprofenDrug
Participants receive paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly over a 14-day period without the addition of famotidine.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol + Ibuprofen + Famotidine | Experimental | Paracetamol and ibuprofen are administered in an alternating regimen over 14 days. Famotidine is given once daily during the same period. Patients on chronic pantoprazole therapy temporarily switch to famotidine during treatment. Receives: Drug: Paracetamol + Ibuprofen + Famotidine |
| Paracetamol + Ibuprofen (No Famotidine) | Active comparator | Paracetamol and ibuprofen are administered concomitantly over 14 days without the addition of famotidine. Receives: Drug: Paracetamol + Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a validated patient-reported questionnaire assessing shoulder pain and function. It consists of 12 items, each scored from 0 to 4, with a total score range of 0 to 48, where higher scores indicate better shoulder function. The primary endpoint is the change in OSS from baseline to follow-up, comparing the two treatment groups.
Measured: Baseline to 12 months
Secondary outcomes (7)
Change in Pain Intensity (Visual Analog Scale, VAS)
Pain intensity is measured using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). The outcome is defined as the change in VAS score from baseline across follow-up time points.
Measured: Baseline, 2 weeks, 6 weeks, 3 months, and 12 months
Change in Size of Calcific Deposits on X-ray
Radiographic assessment of calcific deposits in the shoulder using standard X-ray imaging. The outcome measure is the change in size of calcifications (measured in millimeters) from baseline to 3 months.
Measured: Baseline to 3 months
Use of Additional Therapeutic Interventions
The proportion of patients requiring additional treatments, including physical therapy, extracorporeal shockwave therapy (ESWL), corticosteroid injections, ultrasound-guided barbotage, or arthroscopic surgery.
Measured: Up to 12 months
Incidence of Adverse Events
Number and type of treatment-related adverse events, including gastrointestinal symptoms and other drug-related side effects, recorded throughout the study period.
Measured: Baseline to 12 months
Change in Shoulder Range of Motion
Clinical assessment of active range of motion of the affected shoulder (e.g., abduction, flexion, rotation), evaluated over time and compared between groups.
Measured: 2 weeks, 6 weeks, 3 months, and 12 months
Change in Shoulder Abduction Range of Motion (Degrees)
Active shoulder abduction range of motion is measured in degrees using a goniometer. The outcome measure is the change from baseline at each follow-up time point.
Measured: Baseline, 2 weeks, 6 weeks.
Change in Shoulder Flexion Range of Motion (Degrees)
Active shoulder flexion range of motion is measured in degrees using a goniometer. The outcome measure is the change from baseline at each follow-up time point.
Measured: Baseline, 2 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcific TendinitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marin Glavčić, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539961
- Sponsor's protocol ID
- 2025/1024-7
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Single-Centre Study Evaluating the Efficacy of Therapy With Paracetamol and Ibuprofen, With and Without Famotidine, in the Treatment of Calcific Tendinitis of the Shoulder
- ClinicalTrials.gov ID
- NCT07539961
- Acronym / sponsor ID
- 2025/1024-7
- Conditions
- Calcific Tendinitis
- Keywords
- Calcific tendinitis, Shoulder pain, NSAIDs, Famotidine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Apr 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.
This randomized, open-label, single-centre controlled study evaluates the efficacy and safety of combined paracetamol and ibuprofen therapy with versus without famotidine in the treatment of calcific tendinitis of the shoulder. Outcomes include pain reduction, functional improvement, radiological changes, and need for additional interventions over a 12-month follow-up period.
Detailed description
Calcific tendinitis of the shoulder is a common cause of acute and chronic shoulder pain, often requiring multimodal treatment. Nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics such as paracetamol are frequently used as first-line therapy; however, gastrointestinal adverse effects remain a concern. Famotidine, a histamine H2 receptor antagonist, may improve gastrointestinal safety and potentially influence treatment tolerability.
This study is a randomized, open-label, single-centre controlled trial conducted in the emergency surgical outpatient setting. The objective is to compare the efficacy and safety of alternating paracetamol and ibuprofen therapy with the addition of famotidine versus the same analgesic regimen without famotidine in patients with calcific tendinitis of the shoulder.
Participants will be randomized into two groups:
Intervention group: alternating paracetamol (1000 mg) and ibuprofen (400 mg) for 14 days with famotidine 40 mg once daily Control group: paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly for 14 days without famotidine Patients on chronic pantoprazole therapy will temporarily switch to famotidine during the intervention period.
The primary outcome is the change in pain and shoulder function measured by the Oxford Shoulder Score (OSS) over 12 months. Secondary outcomes include radiographic changes in calcifications, frequency of additional therapeutic interventions (physical therapy, extracorporeal shockwave therapy, corticosteroid injections, barbotage, and arthroscopic surgery), and treatment safety and tolerability.
Patients will be followed at 2 weeks, 6 weeks, 3 months, and 12 months. Assessments include Visual Analog Scale (VAS), OSS questionnaires, range of motion, and radiographic evaluation at 3 months. Adverse events will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol + Ibuprofen + Famotidine | Experimental | Drug: Paracetamol + Ibuprofen + FamotidineParacetamol and ibuprofen are administered in an alternating regimen over 14 days. Famotidine is given once daily during the same period. Patients on chronic pantoprazole therapy temporarily switch to famotidine during treatment. |
| Paracetamol + Ibuprofen (No Famotidine) | Active comparator | Drug: Paracetamol + IbuprofenParacetamol and ibuprofen are administered concomitantly over 14 days without the addition of famotidine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Clinical history of shoulder pain consistent with calcific tendinitis
- Presence of calcifications confirmed by shoulder X-ray
- Ability and willingness to comply with study procedures and follow-up
- Signed informed consent
Key exclusion criteria (5 listed)
- Known allergy or hypersensitivity to paracetamol, ibuprofen, or famotidine
- Active gastrointestinal disease contraindicating NSAID use
- Chronic dual antiplatelet therapy
- Current use of proton pump inhibitors other than pantoprazole (unless temporarily replaced)
- Severe systemic diseases that may interfere with study participation or outcomes
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 |
|---|---|---|
| Paracetamol + Ibuprofen + FamotidineParticipants receive alternating doses of paracetamol (1000 mg) and ibuprofen (400 mg) over a 14-day period, together with famotidine 40 mg once daily. Patients on chronic pantoprazole therapy temporarily switch to famotidine during this period. | Drug | Paracetamol + Ibuprofen + Famotidine |
| Paracetamol + IbuprofenParticipants receive paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly over a 14-day period without the addition of famotidine. | Drug | Paracetamol + Ibuprofen (No Famotidine) |
Primary outcome
Change in Oxford Shoulder Score (OSS)
Time frame: Baseline to 12 months
The Oxford Shoulder Score (OSS) is a validated patient-reported questionnaire assessing shoulder pain and function. It consists of 12 items, each scored from 0 to 4, with a total score range of 0 to 48, where higher scores indicate better shoulder function. The primary endpoint is the change in OSS from baseline to follow-up, comparing the two treatment groups.
7 secondary outcomes
Change in Pain Intensity (Visual Analog Scale, VAS)
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, and 12 months
Change in Size of Calcific Deposits on X-ray
Time frame: Baseline to 3 months
Use of Additional Therapeutic Interventions
Time frame: Up to 12 months
Incidence of Adverse Events
Time frame: Baseline to 12 months
Change in Shoulder Range of Motion
Time frame: 2 weeks, 6 weeks, 3 months, and 12 months
Change in Shoulder Abduction Range of Motion (Degrees)
Time frame: Baseline, 2 weeks, 6 weeks.
Change in Shoulder Flexion Range of Motion (Degrees)
Time frame: Baseline, 2 weeks, 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Calcific Tendinitis
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Calcific Tendinitis of Shoulder
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The Effect of Doppler Ultrasound on Calcified Tendinitis
Calcific Tendinitis of Shoulder
RecruitingObservational study
A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol + Ibuprofen + Famotidine and Paracetamol + Ibuprofen in people with Calcific Tendinitis, run by University Hospital Dubrava.
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 5 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: opening soon, as of the sponsor's last update on 20 Apr 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marin Glavčić, MD (+385 01 290 2571, mglavcic@kbd.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxford Shoulder Score (OSS) (time frame: Baseline to 12 months). 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 20 Apr 2026.