Efficacy of Tinoridine in Treating Pain and Inflammation in Adults
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About
The purpose of this study is to confirm the efficacy of tinoridine hydrochloride (HCL), three times daily (TID), in the treatment of pain and inflammation in patients with acute tonsillitis and/or acute pharyngitis of nonbacterial origin versus placebo.
Full description
Tonsillitis and pharyngitis are the most common upper respiratory tract infections. The signs and symptoms are sore throat, difficulty with swallowing and/or inflamed tonsils and/or pharynx. In most cases these infections are viral in origin.
Tinoridine is a nonsteroid anti-inflammatory drug with a different mechanism of action than common nonsteroidal anti-inflammatory drugs (NSAIDs), which act by inhibiting the cyclooxygenase enzyme and thereby inhibit the synthesis of prostaglandins.
The purpose of this study is to confirm the efficacy of tinoridine in the treatment of pain and inflammation in patients with acute tonsillitis and/or acute pharyngitis of nonbacterial origin versus placebo.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Participants with the following signs & symptoms: sore throat, difficulty with swallowing, and inflamed of pharynx and/or tonsils.
- Onset within 2 days
Exclusion criteria
- Pregnant or lactating women
- Participants hypersensitive to tinoridine
- Participants with fever, peptic ulcer, serious blood abnormality, serious hepatic impairment, serious kidney impairment
- Participants with aspirin-induced asthma
- Drug or alcohol abuse
- Participants receiving analgesic antiinflammatory drug, antibiotic and/or antiviral within 2 days before entering this study
Trial design
Primary purpose
Allocation
Interventional model
Masking
342 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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