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Tinoridine for pain and inflammation in acute tonsillitis/pharyngitis
NCT01224756Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2010
- Primary completion
- Oct 2011
- Countries
- 1
- Sponsor
- Takeda
- Modality
- Small Molecules
- Drugs
- tinoridine
- Conditions
- acute tonsillitisacute pharyngitis
01
Overview
Phase 4, randomised, double-blind trial in acute tonsillitis and acute pharyngitis comparing Tinoridine HCl with Placebo (2 arms). Primary endpoints: Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Sore Throat) at Day 5, Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Painful Swallowing) at Day 5 and 1 more. Started Nov 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tinoridine HCl
Tinoridine HCl 100 mg (2 capsules) TID
Placebo
Placebo TID
03
Endpoints
Primary
Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Sore Throat)
Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Painful Swallowing)
Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Inflamed Pharynx And/Or Tonsils)
Secondary
Change from Baseline in Pain Intensity Measured on a 4-Point Categorical Scale
Change from Baseline in Visual Analogue Scale for Pain Intensity
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