Pain Clinical Trial
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
Verified date | January 2012 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 342 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Takeda |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Sore Throat) in participants receiving tinoridine. | The change between pain and inflammatory signs and symptoms of sore throat on day 5, and sore throat at baseline. The rating scale assesses the disappearance and improvement of pain and inflammatory signs and symptoms as a whole on a 4 point scale (0=poor with no improvement; 1=fair with improvement on day 5; 2=good with improvement on day 3 and disappearance on day 5; and 3=excellent with disappearance on day 3) with a total score range from 0 to 12. Higher scores indicate less pain and inflammatory signs and symptoms. | Baseline and Day 5. | No |
Primary | Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Painful Swallowing) in participants receiving tinoridine. | The change between pain and inflammatory signs and symptoms of painful swallowing on day 5, and painful swallowing at baseline. The rating scale assesses the disappearance and improvement of pain and inflammatory signs and symptoms as a whole on a 4 point scale (0=poor with no improvement; 1=fair with improvement on day 5; 2=good with improvement on day 3 and disappearance on day 5; and 3=excellent with disappearance on day 3) with a total score range from 0 to 12. Higher scores indicate less pain and inflammatory signs and symptoms. | Baseline and Day 5. | No |
Primary | Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Inflamed Pharynx And/Or Tonsils) in participants receiving tinoridine. | The change between pain and inflammatory signs and symptoms of inflamed pharynx and/or tonsils on day 5, and inflamed pharynx and/or tonsils at baseline. The rating scale assesses the disappearance and improvement of pain and inflammatory signs and symptoms as a whole on a 4 point scale (0=poor with no improvement; 1=fair with improvement on day 5; 2=good with improvement on day 3 and disappearance on day 5; and 3=excellent with disappearance on day 3) with a total score range from 0 to 12. Higher scores indicate less pain and inflammatory signs and symptoms. | Baseline and Day 5. | No |
Secondary | Change from Baseline in Pain Intensity Measured on a 4-Point Categorical Scale. | The change between pain intensity measured on a 4-point categorical scale on day 5 and pain intensity at baseline. The rating scale assesses a pain score on a 4 point scale (0=no pain; 1=mild pain; 2=moderate pain; and 3=severe pain) with a total score range from 0 to 12. Higher scores indicate greater pain intensity. | Baseline and Day 5. | No |
Secondary | Change from Baseline in Visual Analogue Scale for Pain Intensity. | The change between pain intensity measured on day 5 and pain intensity at baseline. Subjects marked visual scales (in millimeters) that represented no pain to unbearable pain. Lowest Value: 0 mm. Highest Value: 100 mm. The farther to the left a subject marks, the less intense pain they feel; the farther to the right, the more pain intensity they feel. Higher numbers indicate greater pain intensity. | Baseline and Day 5. | No |
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