NCT01224756 is a Phase 4 clinical trial of Tinoridine HCl in Pain, sponsored by Takeda.

Who is sponsoring NCT01224756?

NCT01224756 is sponsored by Takeda.

What drugs are being tested in NCT01224756?

Interventions in NCT01224756: Tinoridine HCl, Placebo.

What condition does NCT01224756 study?

NCT01224756 studies Pain, Inflammation.

Is NCT01224756 still recruiting?

NCT01224756 is currently completed. Last updated 11 January 2012.

Last reviewed 2012-01-11 · How we verify

NCT01224756

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 11 January 2012

What this trial tests

Phase 4 trial testing Tinoridine HCl in Pain in 342 participants. Completed in 1 October 2011.

Timeline

1 November 2010

Primary endpoint
1 October 2011

1 October 2011

Quick facts

Lead sponsor	Takeda
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	342
Start date	1 November 2010
Primary completion	1 October 2011
Estimated completion	1 October 2011
Sites	4 locations across Indonesia

Drugs / interventions tested

Tinoridine HCl — full drug profile →
Placebo

Conditions studied

Pain — all drugs for Pain →
Inflammation — all drugs for Inflammation →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 60, any sex, with Pain or Inflammation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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 disappe
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=excellen
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 disappearanc

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01224756 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 11 January 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01224756.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing