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Acute Sore Throat Pain Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535079
First Posted: February 17, 2012
Last Update Posted: November 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pierre Fabre Medicament
  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
Intervention Model: Parallel Assignment
Masking: Triple (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
Strefen
Positive control
Drug: Strefen
Single administration

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01535079     History of Changes
Other Study ID Numbers: V00498 TA 2 01
2011-005848-10 ( EudraCT Number )
First Submitted: February 10, 2012
First Posted: February 17, 2012
Last Update Posted: November 12, 2012
Last Verified: October 2012

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
Flurbiprofen
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