Phase III Study of HP-3150 in Patients with Humeroscapular Periarthritis, Cervico-omo-brachial Syndrome and Tenosynovitis

Phase 3

Completed

• Conditions: Humeroscapular periarthritis, cervico-omo-brachial syndrome, tenosynovitis

• Registration Number: JPRN-jRCT2080225041
• Lead Sponsor: Hisamitsu Pharmaceutical Co., Inc.

Brief Summary

The change in the pain VAS score at week 2 showed greater improvement in the 150-mg group than in the placebo group. The efficacy of HP-3150 was confirmed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-29
• Study Completion: 2020-09-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

A patient who was clinically diagnosed with humeroscapular periarthritis, cervico-omo-brachial syndrome, or tenosynovitis not less than 4 weeks ago.
- A patient who has been treated with NSAIDs or acetaminophen for humeroscapular periarthritis, cervico-omo-brachial syndrome, or tenosynovitis for not less than 2 weeks and has not changed their dosage and dose regimen within 2 weeks.

Exclusion Criteria

- A patient whose pain at the site of assessment is thought to be due to visceral disease, bone fracture, trauma, infection, tumor, rheumatoid arthritis, gout, or calcific tendonitis.
- A patient in whom pain in the sites of assessment cannot be assessed appropriately because she/he suffers pain due to complications.
- A patient with serious blood abnormality, liver disorder, renal disorder, hypertension, cardiac dysfunction, or other clinically problematic complications.
- A patient with malignancy.
- A patient with peptic ulcer.
- A patient with current or past history of aspirin-induced asthma.
- A patient with past history of hypersensitivity to NSAIDs.
- A patient who is pregnant, parturient, suspected of being pregnant, or breast-feeding.
- A patient who is known to have dermal sensitivity to external preparations or tapes such as adhesive tapes.
- A patient in whom a planned site of application cannot be secured due to skin abnormality, tattoos or birthmarks, or a patient who frequently gets tanned.

Study & Design

• Study Type: Interventional
• Study Design: Not specified