Efficacy of Tinoridine in Treating Pain and Inflammation in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tinoridine HCl 100 mg (2 capsules) TID

Group Type EXPERIMENTAL

Tinoridine HCl

Intervention Type DRUG

Tinoridine HCl 50 mg, orally, 2 capsules three times daily for up to 4 days.

Placebo TID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tinoridine placebo-matching capsules, orally, 2 capsules three times daily for up to 4 days.

Interventions

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Tinoridine HCl

Tinoridine HCl 50 mg, orally, 2 capsules three times daily for up to 4 days.

Intervention Type DRUG

Placebo

Tinoridine placebo-matching capsules, orally, 2 capsules three times daily for up to 4 days.

Intervention Type DRUG

Other Intervention Names

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Nonflamin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No