臨床研究等提出・公開システム

An open-label, single-group, multi-center, Phase III study to evaluate the efficacy and safety of ST-HT when administered 3 times daily for 3 days to the patients with common cold

Phase III study of ST-HT for common cold

148

The study drug was administered to 148 patients. Males and females were approximately equal in number. The age (mean+/-standard deviation) was 36.0+/-14.3 years and median (minimum-maximum) age was 34.0(15-70) years. The number of days after the onset of symptoms was high at 1 day, 71/147 patients, with a mean of 1.3 days. The generalized severity of the disease was 132/147 patients, with the majority of patients suffering from mild disease. No complications, pre-treatment, concomitant medications, or concomitant therapy were reported in most patients. Seven patients were concomitantly treated with concomitant drugs, but all the concomitant drugs were concomitant drugs (drugs that are not considered to affect the efficacy of the study drug). The concomitant therapy was concomitantly available in one case. All patients had no history of previous treatment.

After obtaining consent from the patient, it is confirmed that a patient meets selection criteria are met but not exclusion criteria. The patient's background is investigated and symptoms of the disease are confirmed. Blood sample is taken for clinical testing and the investigational drug is given to the patient. The patient comes again to the clinic after completing the dose. When the patient comes to the clinic, blood sample is taken for clinical tests after the administration of the investigational drug, and symptoms and adverse events are confirmed by the investigator.

Of the 148 patients included in the safety analysis, 79 adverse events relating to subjective symptoms/objective findings were observed in 55 patients, with an incidence rate of 37.2% (55/148). The most common adverse events were dry mouth (25.0%), somnolence (12.8%) (19/148), and constipation (4.1%) (6/148). The incidence of adverse events related to subjective symptoms/objective findings by severity was 36.5% (54/148 patients) mild and 0.7% (1/148 patients) moderate, but not severe. No serious adverse events or adverse events leading to discontinuation were observed. Four laboratory-related adverse events were observed in one patient, with an incidence rate of 0.7%(1/148). One case of increased alanine aminotransferase, one case of increased aspartate aminotransferase, one case of increased blood creatine phosphokinase, and one case of increased blood lactate dehydrogenase. The severity of the adverse events related to the laboratory tests were all mild and "unrelated" to the study drug.

Of the 147 patients in the Full Analysis Set, the percentage of patients with a general improvement of "moderate improvement or better" (number of cases, 95% confidence interval) was 76.2%(112/147 patients, 68.5-82.8%).

The change in symptom-specific severity scores (mean+/-standard deviation) from the start of treatment (Day 1, Visit 1) to the end of treatment (Day 4, Visit 2) were: runny nose -0.7+/-0.7, nasal congestion -0.7+/-0.7, sneezing -0.7+/-0.6, cough -0.6+/-0.7, volume of sputum -0.4+/-0.7, intensity of coughing when producing sputum -0.4+/-0.8, difficulty in spitting out sputum -0.5+/-1.0, headache -0.7+/-0.8, sore throat -0.7+/-0.8, arthralgia -0.4+/-0.6, myalgia -0.3+/-0.5, fever(body temperature) -0.4+/-0.9, chills -0.7+/-0.7, fatigue -0.8+/-0.7, pharyngeal mucosa (redness/swelling) -0.5+/-0.7 and conjunctiva (redness) -0.1+/-0.4. Scores decreased for all items, except for conjunctiva(redness), which showed a statistically significant decrease at the end of treatment compared to the beginning of treatment (Wilcoxon signed rank test, p<0.001 for all).

The drug ameliorated a variety of symptoms in patients with common cold and was well tolerated in terms of safety and was considered safe for over-the-counter use.

No

https://www.clinicaltrials.jp/file/JyesSBgad

SSP Co., Ltd.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan

-

SSP Co., Ltd.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan

+81-3-6301-3994

-

completed

Oct. 23, 2019

Interventional

Multi-center, Open label, single-arm

treatment purpose

3

1. Common cold patient diagnosed by the invetigator
2. age: 15 years old and above at the time of giving consent
3. Patient who gives written consent
etc.

1. Patinet who was diagnosed as influenza by the investigator
2. Patient with underlying chronic upper airway disease or lowe ariway disease
3. Patine with seasonal nasal allergy during taking the study medication
etc.

Both

Common cold

investigational material(s)
Generic name etc : ST-HT
INN of investigational material : -
Therapeutic category code : 1-- Agents affecting nervous system and sensory organs
Dosage and Administration for Investigational material : three times a day

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

efficacy
Overall improvement

safety
efficacy
Score of improvement by symptoms
Overall safety

+81-92-283-7701

Oct. 04, 2019