Clinical trial NCT01224756: Efficacy of Tinoridine in Treating Pain and Inflammation in Adults
Official title: Safety and Efficacy of Tinoridine in the Treatment of Pain and Inflammation in Patients With Acute Tonsillitis and/or Acute Pharyngitis: a Randomized, Double-blind Study Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Inflammation
Keywords: Tonsillitis
Pharyngitis
Sore Throat
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 acute pharyngitis of nonbacterial origin versus placebo.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Sore Throat) in participants receiving tinoridine.
timeFrame: Baseline and Day 5.
measure: Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Painful Swallowing) in participants receiving tinoridine.
timeFrame: Baseline and Day 5.
measure: 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.
Secondary outcomes:
measure: Change from Baseline in Pain Intensity Measured on a 4-Point Categorical Scale.
timeFrame: Baseline and Day 5.
measure: Change from Baseline in Visual Analogue Scale for Pain Intensity.
timeFrame: Baseline and Day 5.
Other outcomes:
Locations:
city: Semarang
country: Indonesia
state: Central Java
city: Jakarta
country: Indonesia
state: DKI Jakarta
city: Surabaya
country: Indonesia
state: East Java
city: Bandung
country: Indonesia
state: West Java
Study officials:
affiliation: PT. Takeda Indonesia
name: Professor in ENT-HN
role: PRINCIPAL_INVESTIGATOR
References: