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Completed

NCT Number: NCT01785862

Ibuprofen Lozenge in Acute Sore Throat Pain

The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.

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Key information

Conditions

Acute Sore Throat Pain Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gières, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ibuprofen 25 mg

Drug

Lozenge, Oromucosal administration

Placebo

Drug

Lozenge matching V0498 lozenge, Oromucosal administration

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2013
Registry last updated
Jun 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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