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.

Study Overview

• Status: Completed
• Conditions: Pain; Inflammation
• Intervention / Treatment: Drug: Tinoridine HCl; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Semarang, Central Java, Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
  • East Java
    • Surabaya, East Java, Indonesia
  • West Java
    • Bandung, West Java, Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo TID	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	Drug: Tinoridine HCl; Tinoridine HCl 50 mg, orally, 2 capsules three times daily for up to 4 days.; Other Names: Nonflamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Principal Investigator: Professor in ENT-HN, PT. Takeda Indonesia

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 19, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (Estimate): October 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 12, 2012
• Last Update Submitted That Met QC Criteria: January 11, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Drug Therapy; Sore Throat; Pharyngitis; Tonsillitis
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Tinoridine
• Other Study ID Numbers: TI-NF-1001; U1111-1116-6874 (Registry Identifier: WHO)