NCT01535079

Brief Summary

"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."

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 12, 2012

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

February 10, 2012

Last Update Submit

November 9, 2012

Conditions

Acute Sore Throat Pain

Keywords

sore throat paintonsillopharyngitisupper respiratory tract infection

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of Sore Throat Pain Intensity Scale

    60 minutes

Secondary Outcomes (4)

  • Change from baseline of Sore Throat Pain relief Scale

    up to 360 minutes

  • Change of Sore Throat Pain Intensity Scales

    up to 360 minutes

  • Local tolerability examination

    Baseline (before drug intake) and 360 minutes

  • General tolerability (reported adverse events)

    Baseline (before drug intake) and 360 minutes

Study Arms (5)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

V0498TA01A 15 mg

EXPERIMENTAL
Drug: Ibuprofen 15 mg

V0498TA01A 25 mg

EXPERIMENTAL
Drug: Ibuprofen 25 mg

V0498TA01A 35 mg

EXPERIMENTAL
Drug: Ibuprofen 35 mg

Strefen

OTHER

Positive control

Drug: Strefen

Interventions

PlaceboDRUG

Single administration

Placebo
Ibuprofen 35 mgDRUG

Single administration

V0498TA01A 35 mg
Ibuprofen 25 mgDRUG

Single administration

V0498TA01A 25 mg
Ibuprofen 15 mgDRUG

Single administration

V0498TA01A 15 mg
StrefenDRUG

Single administration

Strefen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Eurofins Optimed

Gières, France

Location

Eurofins Optimed Lyon

Pierre-Bénite, France

Location

Unknown Facility

Erfurt, Germany

Location

Unknown Facility

Cardiff, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

IbuprofenFlurbiprofen

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPropionatesAcids, AcyclicBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 17, 2012

Study Start

February 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 12, 2012

Record last verified: 2012-10

Locations

FR(2)DE(1)GB(1)