Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the Shoulder

NCT07539961 | Not Yet Recruiting

• 1 other identifier: 2025/1024-7
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. Outcomes include pain reduction, functional improvement, radiological changes, and need for additional interventions over a 12-month follow-up period.

Conditions

Calcific Tendinitis

Keywords

Calcific tendinitis; Shoulder pain; NSAIDs; Famotidine

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 months

Secondary Outcomes (7)

• Change in Pain Intensity (Visual Analog Scale, VAS)

  Baseline, 2 weeks, 6 weeks, 3 months, and 12 months

• Change in Size of Calcific Deposits on X-ray

  Baseline to 3 months

• Use of Additional Therapeutic Interventions

  Up to 12 months

• Incidence of Adverse Events

  Baseline to 12 months

• Change in Shoulder Range of Motion

  2 weeks, 6 weeks, 3 months, and 12 months

Study Arms (2)

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.

Drug: Paracetamol + Ibuprofen + Famotidine

Paracetamol + Ibuprofen (No Famotidine)

ACTIVE COMPARATOR

Paracetamol and ibuprofen are administered concomitantly over 14 days without the addition of famotidine.

Drug: Paracetamol + Ibuprofen

Interventions

Paracetamol + Ibuprofen + Famotidine DRUG

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 + Ibuprofen + Famotidine

Paracetamol + Ibuprofen DRUG

Participants receive paracetamol (1000 mg) and ibuprofen (400 mg) administered concomitantly over a 14-day period without the addition of famotidine.

Paracetamol + Ibuprofen (No Famotidine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Dubrava: lead

MeSH Terms

Conditions

Shoulder Pain

Interventions

Acetaminophen; Ibuprofen; Famotidine

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Marin Glavčić, MD

CONTACT

+385 01 290 2571; mglavcic@kbd.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04