Trial record 10 of 55 for:    Tonsillitis

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
  Purpose

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 Intervention Phase
Pain
Inflammation
Drug: Tinoridine HCl
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 342
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nonflamin
Placebo Comparator: Placebo TID Drug: Placebo
Tinoridine placebo-matching capsules, orally, 2 capsules three times daily for up to 4 days.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224756

Locations
Indonesia
Semarang, Central Java, Indonesia
Jakarta, DKI Jakarta, Indonesia
Surabaya, East Java, Indonesia
Bandung, West Java, Indonesia
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: Professor in ENT-HN PT. Takeda Indonesia
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01224756     History of Changes
Other Study ID Numbers: TI-NF-1001, U1111-1116-6874
Study First Received: October 19, 2010
Last Updated: January 11, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

Keywords provided by Takeda:
Tonsillitis
Pharyngitis
Sore Throat
Drug Therapy

Additional relevant MeSH terms:
Tonsillitis
Inflammation
Pharyngitis
Pathologic Processes
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Tinoridine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014