Phase III Study of HP-3150 in Patients with Low Back Pai
- Conditions
- ow back pain
- Registration Number
- JPRN-jRCT2080225040
- Lead Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 965
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method