Low back pain
Conditions
Interventions
investigational material(s)
Generic name etc : diclofenac sodium (HP-3150)
INN of investigational material : diclofenac
Therapeutic category code : 114 Antipyretics, analgesics and anti-inflammatory a
Sponsors
Hisamitsu Pharmaceutical Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Japanese patients scheduled for surgery due to low back pain. - Patients with a body mass index (BMI) of at least 18.5 but less than 25.0.
Exclusion criteria
Exclusion criteria: - A patient who has received the following medications or has received the following therapies within 1 week prior to the study: (1) Diclofenac formulation (2) Application of topical agents to the upper arm or lumbar region (3) Nerve blockers, local anesthesia, or trigger point injection to the lumbar region (4) Aspirin - A patient who has received drugs or cholestyramine within 4 weeks prior to the study that may have an interaction with diclofenac. - A patient who has a history of surgical intervention for low back pain. - A patient with concomitant rheumatoid arthritis. - 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 whose body hair does not allow patch to be secured to the application area. - 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 |
|---|---|
| pharmacokinetics - Drug concentration in tissue and plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics safety - The remaining amount of the drug in the investigational drugs - Adverse events, laboratory test values, vital signs | — |
Countries
Japan
Outcome results
None listed