PainPhase 4NCT01224756

Efficacy of Tinoridine in Treating Pain and Inflammation in Adults

A Phase 4 study testing Tinoridine HCl in people with Pain and Inflammation, run by Takeda at 4 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Pain, Inflammation
What is being tested?: Tinoridine HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 342 participants
Where: 4 sitesIndonesia
Study dates: Nov 2010to Oct 2011
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Indonesia4 sites

Study site
Bandung, West Java
Study site
Jakarta, DKI Jakarta
Study site
Semarang, Central Java
Study site
Surabaya, East Java

Other trials in Indonesia

About this study

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

Read the 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.

Conditions: Pain, Inflammation
Being tested: Tinoridine HCl, Placebo
Keywords: Tonsillitis, Pharyngitis, Sore Throat, Drug Therapy
Medical subject headings: Pain, Inflammation, Tonsillitis, Pharyngitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tinoridine HClDrug
Also called Nonflamin
Tinoridine HCl 50 mg, orally, 2 capsules three times daily for up to 4 days.
PlaceboDrug
Tinoridine placebo-matching capsules, orally, 2 capsules three times daily for up to 4 days.

Study groups in NCT01224756
Study group	Role	What they receive
Tinoridine HCl 100 mg (2 capsules) TID	Experimental	Not described Receives: Drug: Tinoridine HCl
Placebo TID	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline and Day 5.

Secondary outcomes (2)

Change from Baseline in Pain Intensity Measured on a 4-Point Categorical Scale.
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.
Measured: Baseline and Day 5.
Change from Baseline in Visual Analogue Scale for Pain Intensity.
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.
Measured: Baseline and Day 5.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Oct 2011

First posted20 Oct 2010 (estimated)
Study startNov 2010
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PainStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 342 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01224756
Sponsor's protocol ID: TI-NF-1001
Other IDs: U1111-1116-6874
Status last verified: Jan 2012
First submitted: 19 Oct 2010
Last updated: 12 Jan 2012
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01224756
Acronym / sponsor ID: TI-NF-1001
Conditions: Pain, Inflammation
Keywords: Tonsillitis, Pharyngitis, Sore Throat, Drug Therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 342 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 20 Oct 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tinoridine HCl 100 mg (2 capsules) TID	Experimental	Drug: Tinoridine HCl
Placebo TID	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tinoridine HClAlso: NonflaminTinoridine HCl 50 mg, orally, 2 capsules three times daily for up to 4 days.	Drug	Tinoridine HCl 100 mg (2 capsules) TID
PlaceboTinoridine placebo-matching capsules, orally, 2 capsules three times daily for up to 4 days.	Drug	Placebo TID

Primary outcome

Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Sore Throat) in participants receiving tinoridine.
Time frame: 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.
Time frame: 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.
Time frame: 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.

2 secondary outcomes

Change from Baseline in Pain Intensity Measured on a 4-Point Categorical Scale.
Time frame: Baseline and Day 5.
Change from Baseline in Visual Analogue Scale for Pain Intensity.
Time frame: Baseline and Day 5.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Professor in ENT-HN principal investigator

PT. Takeda Indonesia

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tinoridine HCl in people with Pain and Inflammation, run by Takeda at 4 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain & Inflammatory Signs & Symptoms of Acute Tonsillitis and/or Acute Pharyngitis (Sore Throat) in participants receiving tinoridine. (time frame: Baseline and Day 5.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01224756.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.