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Phase III Study of HP-3150 in Patients with Low Back Pain

Phase III Study of HP-3150 in Patients with Low Back Pain

965

Sex: 75-mg group: male, 40.4% (55/136 patients); female, 59.6% (81/136 patients). 150-mg group: male, 41.5% (56/135 patients); female, 58.5% (79/135 patients). Placebo group: male, 46.8% (125/267 patients); female, 53.2% (142/267 patients) Mean age (min, max): 75-mg group, 64.1 years (27, 89 years); 150-mg group, 63.0 years (27, 85 years); placebo group, 63.8 years (20, 87 years)

Screened: 974 Enrolled in wash-out period: 965 Single-blind period (placebo run-in period) Enrolled: 659 Discontinued: 121 Double-blind period (treatment period) Enrolled: 538 (75-mg group, 136; 150-mg group, 135; placebo group, 267) Treated: 75-mg group, 136; 150-mg group, 135; placebo group, 267 Discontinued: 75-mg group, 2; 150-mg group, 0; placebo group, 2 Completed: 75-mg group, 134; 150-mg group, 135; placebo group, 265 FAS: 75-mg group, 136; 150-mg group, 135; placebo group, 267 Safety analysis set: 75-mg group, 136; 150-mg group, 135; placebo group, 267

No deaths or serious adverse events (AEs) were reported. The incidence of AEs leading to discontinuation of the investigational product was 0.7% (1/136 patients) in the 75-mg group, 0.0% (0/135 patients) in the 150-mg group, and 0.4% (1/267 patients) in the placebo group. The incidence of AEs was 27.2% (37/136 patients) in the 75-mg group, 29.6% (40/135 patients) in the 150-mg group, and 28.1% (75/267 patients) in the placebo group. The incidence of adverse drug reactions (ADRs; i.e., treatment-related AEs) was 14.0% (19/136 patients) in the 75-mg group, 12.6% (17/135 patients) in the 150-mg group, and 19.1% (51/267 patients) in the placebo group. The majority of AEs were mild. AEs with an incidence of 5% or more were blood creatine phosphokinase increased (5.1%) in the 75-mg group, blood creatine phosphokinase increased (5.2%) in the 150-mg group, and application site pruritus (12.4%), and application site erythema (9.4%) in the placebo group.

The difference between the 150-mg and placebo groups in terms of least-squares (LS) mean change from baseline in mean 3-day pain VAS (visual analogue scale) score after 2 weeks of treatment was -5.67 mm (95% CI, -9.34 to -2.00 mm; P = 0.0025, analysis of covariance [ANCOVA], with treatment group and baseline mean 3-day pain VAS score as explanatory variables), demonstrating the superiority of the 150-mg group to the placebo group. In addition, the difference between the 75-mg and placebo groups in terms of LS mean change from baseline was -5.68 mm (95% CI, -9.34 to -2.01 mm; P = 0.0024, ANCOVA, with treatment group and baseline mean 3-day pain VAS score as explanatory variables), demonstrating the superiority of the 75-mg group to the placebo group.

Compared with the placebo group, the 150-mg and 75-mg groups achieved better results with regard to change from baseline in RDQ (Roland-Morris Disability Questionnaire) score, the proportion of patients who were Very satisfied or Satisfied with their analgesic treatment, and the proportion of patients with a global improvement rating of Much improved or Improved.

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.

June. 20, 2023

Feb. 01, 2023

https://link.springer.com/article/10.1007/s40122-023-00478-1

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

Feb. 03, 2020

Interventional

Multicenter, randomized, placebo-controlled, double-blind, parallel-group comparison

treatment purpose

3

- 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.

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 (low 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 : Transdermal, once daily (high dose)

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

efficacy
confirmatory
- Change from baseline in the visual analog scale values

safety
efficacy
- Change from baseline in scores of the Roland-Morris Disability Questionnaire
- Adverse events, laboratory test values, vital signs, ECG

Dec. 19, 2019