Efficacy of Tinoridine in Treating Pain and Inflammation in Adults
This study has been completed.
Sponsor:
P.T. Takeda Indonesia
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( P.T. Takeda Indonesia )
ClinicalTrials.gov Identifier:
NCT01224756
First received: October 19, 2010
Last updated: January 11, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Global Research & Development Center, Inc.:
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
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
P.T. Takeda Indonesia
Investigators
| Principal Investigator: | Professor in ENT-HN | PT. Takeda Indonesia |
More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( P.T. Takeda Indonesia ) |
| 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 Global Research & Development Center, Inc.:
|
Tonsillitis Pharyngitis Sore Throat Drug Therapy |
Additional relevant MeSH terms:
|
Inflammation Pharyngitis Tonsillitis 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 May 19, 2013