Efficacy of Tinoridine in Treating Pain and Inflammation in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01224756
First received: October 19, 2010
Last updated: January 11, 2012
Last verified: January 2012

October 19, 2010
January 11, 2012
November 2010
October 2011   (final data collection date for primary outcome measure)
  • Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Sore Throat) in participants receiving tinoridine. [ Time Frame: Baseline and Day 5. ] [ Designated as safety issue: No ]
    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.
  • Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Painful Swallowing) in participants receiving tinoridine. [ Time Frame: Baseline and Day 5. ] [ Designated as safety issue: No ]
    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.
  • Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Inflamed Pharynx And/Or Tonsils) in participants receiving tinoridine. [ Time Frame: Baseline and Day 5. ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01224756 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Pain Intensity Measured on a 4-Point Categorical Scale. [ Time Frame: Baseline and Day 5. ] [ Designated as safety issue: No ]
    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.
  • Change from Baseline in Visual Analogue Scale for Pain Intensity. [ Time Frame: Baseline and Day 5. ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Efficacy of Tinoridine in Treating Pain and Inflammation in Adults
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Inflammation
  • Drug: Tinoridine HCl
    Tinoridine HCl 50 mg, orally, 2 capsules three times daily for up to 4 days.
    Other Name: Nonflamin
  • Drug: Placebo
    Tinoridine placebo-matching capsules, orally, 2 capsules three times daily for up to 4 days.
  • Experimental: Tinoridine HCl 100 mg (2 capsules) TID
    Intervention: Drug: Tinoridine HCl
  • Placebo Comparator: Placebo TID
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
342
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01224756
TI-NF-1001, U1111-1116-6874
Yes
Takeda
Takeda
Not Provided
Principal Investigator: Professor in ENT-HN PT. Takeda Indonesia
Takeda
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP