Acute Sore Throat Pain Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01535079
First received: February 10, 2012
Last updated: November 9, 2012
Last verified: October 2012
  Purpose

"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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline of Sore Throat Pain relief Scale [ Time Frame: up to 360 minutes ] [ Designated as safety issue: No ]
  • Change of Sore Throat Pain Intensity Scales [ Time Frame: up to 360 minutes ] [ Designated as safety issue: No ]
  • Local tolerability examination [ Time Frame: Baseline (before drug intake) and 360 minutes ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

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
Strefen
Positive control
Drug: Strefen
Single 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535079

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

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01535079     History of Changes
Other Study ID Numbers: V00498 TA 2 01, 2011-005848-10
Study First Received: February 10, 2012
Last Updated: November 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
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
Flurbiprofen
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 April 20, 2014