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Acute Sore Throat Pain Study

This study has been completed.
Information provided by (Responsible Party):
Pierre Fabre Medicament Identifier:
First received: February 10, 2012
Last updated: November 9, 2012
Last verified: October 2012

"Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature.

The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain."

Condition Intervention Phase
Acute Sore Throat Pain
Drug: Placebo
Drug: Ibuprofen 35 mg
Drug: Ibuprofen 25 mg
Drug: Ibuprofen 15 mg
Drug: Strefen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain

Resource links provided by NLM:

Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Change from baseline of Sore Throat Pain Intensity Scale [ Time Frame: 60 minutes ]

Secondary Outcome Measures:
  • Change from baseline of Sore Throat Pain relief Scale [ Time Frame: up to 360 minutes ]
  • Change of Sore Throat Pain Intensity Scales [ Time Frame: up to 360 minutes ]
  • Local tolerability examination [ Time Frame: Baseline (before drug intake) and 360 minutes ]
    Mouth examination including extent of erythema, edema, petechial hemorrhages, ulceration (4 point scale : none, mild, moderate and severe).

  • General tolerability (reported adverse events) [ Time Frame: Baseline (before drug intake) and 360 minutes ]

Enrollment: 186
Study Start Date: February 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Single administration
Experimental: V0498TA01A 15 mg Drug: Ibuprofen 15 mg
Single administration
Experimental: V0498TA01A 25 mg Drug: Ibuprofen 25 mg
Single administration
Experimental: V0498TA01A 35 mg Drug: Ibuprofen 35 mg
Single administration
Positive control
Drug: Strefen
Single administration


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male or female patients 18 years and older
  • patients with a sore throat associated or not with an Upper Respiratory Tract Infection ≥ 24 hours and ≤ 5 days duration, in the absence of Streptococcus group A

Exclusion Criteria:

  • patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients.
  • patients having used analgesics or antiseptics or any topical throat treatment or any local medication containing a local oral anaesthetic within 6 hours before study entry and who use analgesics more than ≥ 3 times per week.
  • patients having used any anti inflammatory treatment or any long-acting or slow release analgesics within 12 hours before study entry
  • patients having taken antibiotics within 14 days before study entry.
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Please refer to this study by its identifier: NCT01535079

Eurofins Optimed
Gières, France
Eurofins Optimed Lyon
Pierre Bénite, France
Erfurt, Germany
United Kingdom
Cardiff, United Kingdom
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

Responsible Party: Pierre Fabre Medicament Identifier: NCT01535079     History of Changes
Other Study ID Numbers: V00498 TA 2 01
2011-005848-10 ( EudraCT Number )
Study First Received: February 10, 2012
Last Updated: November 9, 2012

Keywords provided by Pierre Fabre Medicament:
sore throat pain
upper respiratory tract infection

Additional relevant MeSH terms:
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017