Efficacy of Tinoridine in Treating Pain and Inflammation in Adults

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT01224756

Collaborator

(none)

342

Enrollment

Locations

Arms

Duration (Months)

85.5

Patients Per Site

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Inflammation	Drug: Tinoridine HCl Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

342 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo TID	Drug: Placebo Tinoridine placebo-matching capsules, orally, 2 capsules three times daily for up to 4 days.

Arm

Intervention/Treatment

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

Placebo Comparator: Placebo TID

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Sore Throat) in participants receiving tinoridine. [Baseline and Day 5.]
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. [Baseline and Day 5.]
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. [Baseline and Day 5.]
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.

Secondary Outcome Measures

Change from Baseline in Pain Intensity Measured on a 4-Point Categorical Scale. [Baseline and Day 5.]
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. [Baseline and Day 5.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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