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Completed

NCT Number: NCT01535079

Acute Sore Throat Pain Study

"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."

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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 2

Primary location

Eurofins Optimed, 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 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.

Treatment and study plan

Placebo

Drug

Single administration

Ibuprofen 35 mg

Drug

Single administration

Ibuprofen 25 mg

Drug

Single administration

Ibuprofen 15 mg

Drug

Single administration

Strefen

Drug

Single administration

Primary outcomes

  1. Change from baseline of Sore Throat Pain Intensity Scale

    Time frame: 60 minutes

Secondary outcomes

  1. Change from baseline of Sore Throat Pain relief Scale

    Time frame: up to 360 minutes

  2. Change of Sore Throat Pain Intensity Scales

    Time frame: up to 360 minutes

  3. 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).

  4. General tolerability (reported adverse events)

    Time frame: Baseline (before drug intake) and 360 minutes

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2012
Registry last updated
Nov 12, 2012

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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