Status:
COMPLETED
Efficacy of Tinoridine in Treating Pain and Inflammation in Adults
Lead Sponsor:
Takeda
Conditions:
Pain
Inflammation
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
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 acu...
Detailed 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 c...
Eligibility Criteria
Inclusion
- Participants with the following signs \& symptoms: sore throat, difficulty with swallowing, and inflamed of pharynx and/or tonsils.
- Onset within 2 days
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT01224756
Start Date
November 1 2010
End Date
October 1 2011
Last Update
January 12 2012
Active Locations (4)
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1
Semarang, Central Java, Indonesia
2
Jakarta, DKI Jakarta, Indonesia
3
Surabaya, East Java, Indonesia
4
Bandung, West Java, Indonesia