Ibuprofen Lozenge in Acute Sore Throat Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01785862
First received: February 5, 2013
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Acute Sore Throat Pain
Drug: Ibuprofen 25 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Total Pain relief over 2 hours [ Time Frame: 0-2 hours post-dose ] [ Designated as safety issue: No ]
    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


Enrollment: 427
Study Start Date: February 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785862

Locations
France
Gières, France
Germany
Erfurt, Germany
Latvia
Balvi, Latvia
Daugavpils, Latvia
Jekabpils, Latvia
Jelgava, Latvia
Kuldiga, Latvia
Liepaja, Latvia
Ogre, Latvia
Ogres Municipality, Latvia
Riga, Latvia
Saldus, Latvia
United Kingdom
Cardiff, United Kingdom
Glasgow, United Kingdom
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01785862     History of Changes
Other Study ID Numbers: V00498 TA 3 01, 2012-004423-20
Study First Received: February 5, 2013
Last Updated: June 26, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Latvia: State Agency of Medicines
Latvia: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014