Phase III Study of HP-3150 in Patients with Low Back Pain

Hisamitsu Pharmaceutical Co., Inc.0 个研究点目标入组 965 人开始时间: 2020年1月28日最近更新: 2023年10月17日

试验速览

The superiority of HP-3150 150 mg and 75 mg to placebo in the change from baseline in pain VAS score at week 2 was verified.

•A patient who was clinically diagnosed with low back pain not less than 12 weeks ago.
•- A patient who has been treated with NSAIDs or acetaminophen for low back pain for not less than 4 weeks and has not changed their dosage and dose regimen within 4 weeks.

•- A patient in whom pain in the low back 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.

发起方