Ibuprofen Lozenge in Acute Sore Throat Pain
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ClinicalTrials.gov Identifier: NCT01785862 |
Recruitment Status :
Completed
First Posted : February 7, 2013
Last Update Posted : June 27, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Sore Throat Pain | Drug: Ibuprofen 25 mg Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 427 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain. |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Drug
V0498, Ibuprofen 25 mg
|
Drug: Ibuprofen 25 mg
Lozenge, Oromucosal administration |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Lozenge matching V0498 lozenge, Oromucosal administration |
- Total Pain relief over 2 hours [ Time Frame: 0-2 hours post-dose ]Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- male or female aged at least 18 years old
- patient with an acute sore throat
Exclusion Criteria:
- Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
- Oro-pharyngeal paresthesia or mycosis
- Severely traumatised and/or very severe oromucosal inflammation
- Tonsillopharyngectomy
- Peritonsillar abscess
- Hypersensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) (including bronchospasm) or to excipients
- Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including NonSteroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
- Any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation
- Any paracetamol intake within 6 hours before randomisation
- Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
- Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation
- Heavy smokers (>20 cigarettes/day)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785862
France | |
Gières, France | |
Germany | |
Erfurt, Germany | |
Latvia | |
Balvi, Latvia | |
Daugavpils, Latvia | |
Jekabpils, Latvia | |
Jelgava, Latvia | |
Kuldiga, Latvia | |
Liepaja, Latvia | |
Ogres Municipality, Latvia | |
Ogre, Latvia | |
Riga, Latvia | |
Saldus, Latvia | |
United Kingdom | |
Cardiff, United Kingdom | |
Glasgow, United Kingdom |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pierre Fabre Medicament |
ClinicalTrials.gov Identifier: | NCT01785862 History of Changes |
Other Study ID Numbers: |
V00498 TA 3 01 2012-004423-20 ( EudraCT Number ) |
First Posted: | February 7, 2013 Key Record Dates |
Last Update Posted: | June 27, 2013 |
Last Verified: | June 2013 |
sore throat pain tonsillopharyngitis upper respiratory tract infection |
Pharyngitis Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections Respiratory Tract Diseases Otorhinolaryngologic Diseases Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics 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 |