NCT01465009

Brief Summary

The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of sore throat associated with a common cold. The study is designed to develop a treatment method against sore throat associated with a common cold which will have more advantages for patients than the methods that are currently available.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
508

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

8 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

November 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
Last Updated

December 11, 2014

Status Verified

November 1, 2011

First QC Date

May 17, 2011

Last Update Submit

December 10, 2014

Conditions

Common ColdPharyngitisTonsillitis

Keywords

Sore Throat

Outcome Measures

Primary Outcomes (1)

  • Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol

    For 6 hours after drug intake

Secondary Outcomes (5)

  • Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo

    For 6 hours after drug intake

  • Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol

    For 6 hours after drug intake

  • Total pain relief of Acetylsalicylic Acid in comparison to Placebo

    For 6 hours after drug intake

  • Evaluation of Upper Respiratory Tract Infection symtoms

    2 hours after drug intake

  • Adverse Event collection

    Up to 17 days after Screening

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 2

ACTIVE COMPARATOR
Drug: Paracetamol

Arm 3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Acetylsalicylic acid (Aspirin, BAYE4465)DRUG

Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol

Arm 1
ParacetamolDRUG

Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid

Arm 2
PlaceboDRUG

Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol

Arm 3

Eligibility Criteria

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

You may qualify if:

  • Male and female patients
  • Onset of common cold within the past 5 days
  • Current sore throat
  • Confirmed presence of a tonsillo-pharyngitis

You may not qualify if:

  • Hypersensitivity to acetylsalicylic acid, salicylates, paracetamol, or any other NSAID
  • Pregnant or lactating women
  • History or acute state of peptic ulceration or gastrointestinal bleeding
  • History of bleeding tendency
  • History of asthma
  • Inability to breathe through the nose or a history of chronic mouth breathing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Reading, Berkshire, RG2 7AG, United Kingdom

Location

Unknown Facility

Manchester, Greater Manchester, M15 6SX, United Kingdom

Location

Unknown Facility

Chorley, Lancashire, PR7 1NY, United Kingdom

Location

Unknown Facility

Wigan, Lancashire, WN6 9EW, United Kingdom

Location

Unknown Facility

Liverpool, Merseyside, L1 9AD, United Kingdom

Location

Unknown Facility

Liverpool, Merseyside, L22 0LG, United Kingdom

Location

Unknown Facility

Cardiff, South Glamorgan, CF1 3US, United Kingdom

Location

Unknown Facility

Birmingham, West Midlands, B15 2SQ, United Kingdom

Location

MeSH Terms

Conditions

Common ColdPharyngitisTonsillitis

Interventions

AspirinAcetaminophen

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2011

First Posted

November 4, 2011

Study Start

November 1, 2003

Study Completion

March 1, 2005

Last Updated

December 11, 2014

Record last verified: 2011-11

Locations

GB(8)