Low back pain
Conditions
Sponsors
Hisamitsu Pharmaceutical Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy confirmatory - Change from baseline in the visual analog scale values | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - Change from baseline in scores of the Roland-Morris Disability Questionnaire - Adverse events, laboratory test values, vital signs, ECG | — |
Countries
Japan
Outcome results
None listed