Table 3 Exclusion criteria
We exclude patients with any of the following criteria: | |
1) | Patients with severe heart disease, renal disease, respiratory disease, blood disease, diabetes, coagulopathy, hepatic injury, or renal disorder |
2) | Patients with gastric ulcer |
3) | Patient with aspirin-induced asthma or history of aspirin |
4) | Patients who have had a history of allergic symptoms such as itching and rash, or taking zaltoprofen (Soleton tablet 80 mg, Peon tablet 80 mg, etc.) previously |
5) | Hypersensitivity to additives in zaltoprofen (lactose hydrate, corn starch, cellulose, silicic anhydride, hydroxypropyl cellulose, carmellose Ca, stearic acid Mg, polysorbate 80, hypromellose, titanium oxide, talc, carnauba wax) or patient with a history of hypersensitivity |
6) | Patients who are administered any of the following agents within 14 days prior to enrollment: tyrosine kinase inhibitors, nonsteroidal anti-inflammatory drugs, thiazolidine derivatives, and drugs with a thiazolysine ring |
7) | Patients who have an active range of motion limitation of > 20% with respect to the healthy joint |
8) | Patients whose joint space has disappeared by standing position X-ray photography |
9) | Patients who are inappropriate for examinations, such as MRI and PETa |
10) | Patients who are pregnant or lactating or patients who do not agree to contraception from the final administration of the study drug to 90 days thereafter |
11) | Patients who have difficulty taking oral medications |
12) | Patients who were using other investigational drugs or using the investigational drug within 3 months prior to the study drug administration |
13) | A patient whose investigator or clinical trial doctor judged him/her unsuitable for participation in this trial due to other reasons |