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A clinical pharmacological study of HP-3150 in patients with low back pain

A clinical pharmacological study of HP-3150 in patients with low back pain

32

Sex: Low back application group (application of HP-3150 150 mg to affected area): male, 3/8 patients; female, 5/8 patients. Upper arm application group (application of HP-3150 150 mg to unaffected area): male, 7/8 patients; female, 1/8 patients. DF-Na tape group (application of existing diclofenac sodium tape 15 mg to affected area): male, 3/8 patients; female, 5/8 patients. DF-Na tablet group (administration of diclofenac sodium tablet 25 mg): male, 4/8 patients; female, 4/8 patients Mean age (min, max): low back application group, 60.9 years (33, 80 years); upper arm application group, 61.6 years (37, 80 years); DF-Na tape group, 73.5 years (52, 86 years); DF-Na tablet group, 59.4 years (28, 78 years)

Screened: 32 Enrolled: 32 (low back application group, 8; upper arm application group, 8; DF-Na tape group, 8; DF-Na tablet group, 8) Treated/Completed: low back application group, 8; upper arm application group, 8; DF-Na tape group, 8; DF-Na tablet group; 8 Pharmacokinetic analysis set/Safety analysis set: low back application group, 8; upper arm application group, 8; DF-Na tape group, 8; DF-Na tablet group, 8

No adverse events were observed in any group.

Mean tissue (muscle or ligament) diclofenac (DF) concentrations were highest in the DF-Na tablet group (muscle, 20.9 ng/g) and the low back application group (ligament, 15.6 ng/g). Mean plasma DF concentrations were highest in the DF-Na tablet group (212 ng/mL). In the low back application group, upper arm application group, and DF-Na tablet group, plasma DF concentrations were the highest in muscle, ligament, and plasma. In the DF-Na tape group, muscle DF concentrations were the highest in muscle, ligament, and plasma.

The estimated mean drug absorption rates were as follows: low back application group, 12.6%; upper arm application group, 11.5%; and DF-Na tape group, 15.6%.

Tissue (muscle or ligament) DF concentrations in the affected area (low back) were highest when the DF-Na tablet was administered (muscle) and when the HP-3150 was applied to the low back (ligament).

June. 20, 2023

No

Hisamitsu Pharmaceutical Co., Inc.

2-4-1 Marunouchi, Chiyoda-ku, Tokyo

shikenjoho@hisamitsu.co.jp

Hisamitsu Pharmaceutical Co., Inc.

2-4-1 Marunouchi, Chiyoda-ku, Tokyo

+81-3-5293-1734

shikenjoho@hisamitsu.co.jp

completed

June. 17, 2020

Interventional

Multicenter, open-label, active-controlled, randomized, parallel-group comparison

other

3

- 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.

- 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.

Both

Low back pain

investigational material(s)
Generic name etc : diclofenac sodium (HP-3150)
INN of investigational material : diclofenac
Therapeutic category code : 114 Antipyretics, analgesics and anti-inflammatory agents
Dosage and Administration for Investigational material : Transdermal, Application site: The affected area, Single dose
Generic name etc : diclofenac sodium (HP-3150)
INN of investigational material : diclofenac
Therapeutic category code : 114 Antipyretics, analgesics and anti-inflammatory agents
Dosage and Administration for Investigational material : Transdermal, Application site: Anywhere other than the affected area, Single dose

control material(s)
Generic name etc : diclofenac sodium
INN of investigational material : diclofenac
Therapeutic category code : 264 Analgesics, anti-itchings, astrigents and anti-inflammatory agents
Dosage and Administration for Investigational material : Transdermal, Application site: The affected area, Single dose
Generic name etc : diclofenac sodium
INN of investigational material : diclofenac
Therapeutic category code : 114 Antipyretics, analgesics and anti-inflammatory agents
Dosage and Administration for Investigational material : Oral, Single dose

pharmacokinetics
- Drug concentration in tissue and plasma

pharmacokinetics
safety
- The remaining amount of the drug in the investigational drugs
- Adverse events, laboratory test values, vital signs

Mar. 26, 2020