Efficacy of Tinoridine in Treating Pain and Inflammation in Adults

NCT01224756 | Completed Phase 4 DMC

• 2 other identifiers: TI-NF-1001U1111-1116-6874
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 4

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.

Conditions

Pain; Inflammation

Keywords

Tonsillitis; Pharyngitis; Sore Throat; Drug Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change from Baseline in Pain Intensity Measured on a 4-Point Categorical Scale.

  Baseline and Day 5.

• Change from Baseline in Visual Analogue Scale for Pain Intensity.

  Baseline and Day 5.

Study Arms (2)

Tinoridine HCl 100 mg (2 capsules) TID

EXPERIMENTAL

Drug: Tinoridine HCl

Placebo TID

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tinoridine HCl DRUG

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

Also known as: Nonflamin

Tinoridine HCl 100 mg (2 capsules) TID

Placebo DRUG

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

Placebo TID

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants with the following signs \& symptoms: sore throat, difficulty with swallowing, and inflamed of pharynx and/or tonsils.
• Onset within 2 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Unknown Facility

Semarang, Central Java, Indonesia

Location

Unknown Facility

Jakarta, DKI Jakarta, Indonesia

Location

Unknown Facility

Surabaya, East Java, Indonesia

Location

Unknown Facility

Bandung, West Java, Indonesia

Location

MeSH Terms

Conditions

Pain; Inflammation; Tonsillitis; Pharyngitis

Interventions

tinoridine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Professor in ENT-HN

  PT. Takeda Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 12, 2012

Record last verified: 2012-01

Locations

ID (4)