CompletedPhase 4

Efficacy of Tinoridine in Treating Pain and Inflammation in Adults

Indonesia342 participantsStarted 2010-11

Plain-language 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 acute pharyngitis of nonbacterial origin versus placebo.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Sore Throat) in participants receiving tinoridine.

Timeframe: Baseline and Day 5.

Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Painful Swallowing) in participants receiving tinoridine.

Timeframe: Baseline and Day 5.

Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Inflamed Pharynx And/Or Tonsils) in participants receiving tinoridine.

Timeframe: Baseline and Day 5.

Trial details

NCT IDNCT01224756

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10

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