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Long-term Study of HP-3150 in Patients with Low Back Pain

Long-term Study of HP-3150 in Patients with Low Back Pain

136

Sex: male, 51.9% (70/135 patients); female, 48.1% (65/135 patients) Mean age (min, max): 59.5 years (34, 85 years)

Screened: 146 Enrolled: 136 Treated: 135 Discontinued: 20 Completed: 115 Safety analysis set: 135 FAS: 135

No deaths were reported. The incidence of serious adverse events (AEs) other than death was 3.7% (5/135 patients), and the serious AEs observed were diverticulum intestinal haemorrhagic, thermal burn, intervertebral disc protrusion, spinal cord neoplasm, and intracranial aneurysm in 1 patient each. Among these serious AEs, diverticulum intestinal haemorrhagic was a treatment-related AE. The incidence of AEs leading to discontinuation of the investigational product was 6.7% (9/135 patients). The incidence of AEs was 80.0% (108/135 patients), and the incidence of adverse drug reactions (ADRs; i.e., treatment-related AEs) was 36.3% (49/135 patients). AEs with an incidence of 5% or more were application site pruritus (21.5%), blood lactate dehydrogenase increased (18.5%), blood creatine phosphokinase increased (15.6%), application site erythema (13.3%), blood urine present and protein urine present (10.4% each), aspartate aminotransferase increased (8.9%), gamma-glutamyltransferase increased (6.7%), alanine aminotransferase increased (5.9%), and ligament sprain and eosinophil percentage increased (5.2% each). The majority of AEs were mild.

The mean (SD) baseline pain visual analogue scale (VAS) score in the FAS was 43.7 (20.4) mm. The mean (SD) changes in pain VAS score from baseline were as follows: week 2, -8.2 (18.5) mm; week 4, -12.0 (18.5) mm; week 12, -16.8 (20.4) mm; week 24, -21.0 (22.2) mm; week 36, -21.5 (24.1) mm; week 52, -26.6 (22.1) mm; and final assessment, -23.7 (24.9) mm.

Improvements were observed in RDQ (Roland-Morris Disability Questionnaire), patient satisfaction, and global improvement, and the persistence of the effects up to week 52 was confirmed.

Repeated application of HP-3150 (150 mg) for 52 weeks in patients with low back pain showed an improvement in pain VAS score, and the persistence of the effect up to week 52 was confirmed. Most of the AEs occurring in patients were mild in severity, indicating no major safety concerns.

June. 20, 2023

Feb. 28, 2022

https://www.pieronline.jp/content/article/0386-3603/50020/213

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

Jan. 28, 2020

Interventional

Multicenter, open-label, uncontrolled

treatment purpose

3

- A patient who was clinically diagnosed with low back pain not less than 12 weeks ago and requires long-term treatment with NSAIDs.

- 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.

Both

Low back pain

investigational material(s)
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 : Transdermal, once daily

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
- Incidence of adverse events

efficacy
pharmacokinetics
- Visual analog scale values and their change from baseline
- Plasma levels of diclofenac

Dec. 19, 2019