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Phase III Study of HP-3150 in Patients with Humeroscapular Periarthritis, Cervico-omo-brachial Syndrome and Tenosynovitis

Phase III Study of HP-3150 in Patients with Humeroscapular Periarthritis, Cervico-omo-brachial Syndrome and Tenosynovitis

342

Sex: 150-mg group: male, 29.5% (23/78 patients); female, 70.5% (55/78 patients). Placebo group: male, 41.6% (32/77 patients); female, 58.4% (45/77 patients) Mean age (min, max): 150-mg group, 59.6 years (24, 93 years); placebo group, 57.3 years (29, 84 years)

Screened: 345 Enrolled in wash-out period: 342 Single-blind period (placebo run-in period) Enrolled: 204 Discontinued: 49 Double-blind period (treatment period) Enrolled: 155 (150-mg group, 78; placebo group, 77) Treated: 150-mg group, 78; placebo group, 77 Discontinued: 150-mg group, 1; placebo group, 0 Completed: 150-mg group, 77; placebo group, 77 FAS: 150-mg group, 78; placebo group, 77 Safety analysis set: 150-mg group, 78; placebo group, 77

No deaths were reported. The incidence of serious adverse events (AEs) other than death was 1.3% (1/78 patients) in the 150-mg group and 0.0% (0/77 patients) in the placebo group. The serious AEs reported in the 150-mg group were acoustic neuroma and hypertensive emergency (1 patient each, the same patient), and a causal relationship with the investigational product was ruled out for both events. The incidence of AEs leading to discontinuation of the investigational product was 1.3% (1/78 patients) in the 150-mg group and 0.0% (0/77 patients) in the placebo group. The incidence of AEs was 32.1% (25/78 patients) in the 150-mg group and 42.9% (33/77 patients) in the placebo group. The incidence of adverse drug reactions (ADRs; i.e., treatment-related AEs) was 11.5% (9/78 patients) in the 150-mg group and 22.1% (17/77 patients) in the placebo group. The majority of AEs were mild. AEs with an incidence of 5% or more were blood creatine phosphokinase increased (6.4%) and blood urine present and blood urea increased (5.1% each) in the 150-mg group and application site pruritus (14.3%), application site erythema (10.4%), blood urine present (9.1%), and blood creatine phosphokinase increased (5.2%) 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 -4.10 mm (95% CI, -8.64 to 0.44 mm, analysis of covariance [ANCOVA], with treatment group and baseline mean 3-day pain VAS score as explanatory variables). The 150-mg group showed greater improvement than the placebo group.

Compared with the placebo group, the 150-mg group achieved better results with regard to 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 change in the pain VAS score at week 2 showed greater improvement in the 150-mg group than in the placebo group. The efficacy of HP-3150 was confirmed.

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

Feb. 03, 2020

Interventional

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

treatment purpose

3

- A patient who was clinically diagnosed with humeroscapular periarthritis, cervico-omo-brachial syndrome, or tenosynovitis not less than 4 weeks ago.
- A patient who has been treated with NSAIDs or acetaminophen for humeroscapular periarthritis, cervico-omo-brachial syndrome, or tenosynovitis for not less than 2 weeks and has not changed their dosage and dose regimen within 2 weeks.

- A patient whose pain at the site of assessment is thought to be due to visceral disease, bone fracture, trauma, infection, tumor, rheumatoid arthritis, gout, or calcific tendonitis.
- A patient in whom pain in the sites 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

Humeroscapular periarthritis, cervico-omo-brachial syndrome, tenosynovitis

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 : placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

efficacy
- Change from baseline in the visual analog scale values

safety
efficacy
- Category aggregation of patient satisfaction
- Adverse events, laboratory test values, vital signs, ECG

Dec. 19, 2019