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

Hisamitsu Pharmaceutical Co., Inc.1 个研究点目标入组 195 人开始时间: 待定最近更新: 2023年6月25日

试验速览

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研究类型: Interventional
干预模型: Multicenter, randomized, placebo-controlled, double-blind, parallel-group comparison
主要目的: Treatment Purpose

•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.

•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.

efficacy - Change from baseline in the visual analog scale values

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