ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT0146500911381NCT01465009Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common ColdDouble-blind, Randomized, Placebo-controlled, Single Dose, Parallel Group Study Evaluating Efficacy and Safety of 1000 mg Acetylsalicylic Acid and 1000 mg Paracetamol in Adult Patients With Sore Throat Associated With a Common ColdBayerIndustryNo
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.
CompletedNovember 2003March 2005Phase 4InterventionalNoRandomizedParallel AssignmentTreatmentQuadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to ParacetamolFor 6 hours after drug intakePain intensity difference to baseline of Acetylsalicylic Acid in comparison to PlaceboFor 6 hours after drug intakeTotal pain relief of Acetylsalicylic Acid in comparison to ParacetamolFor 6 hours after drug intakeTotal pain relief of Acetylsalicylic Acid in comparison to PlaceboFor 6 hours after drug intakeEvaluation of Upper Respiratory Tract Infection symtoms2 hours after drug intakeAdverse Event collectionUp to 17 days after Screening3508Common ColdPharyngitisTonsillitisArm 1ExperimentalArm 2Active ComparatorArm 3Placebo ComparatorDrugAcetylsalicylic acid (Aspirin, BAYE4465)Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to ParacetamolArm 1DrugParacetamolSingle Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic AcidArm 2DrugPlaceboSingle Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to ParacetamolArm 3
Inclusion Criteria:
- Male and female patients
- Onset of common cold within the past 5 days
- Current sore throat
- Confirmed presence of a tonsillo-pharyngitis
Exclusion Criteria:
- 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
- Other exclusion criteria may apply
All18 YearsN/ANoBayer Study DirectorStudy DirectorBayerReadingBerkshireRG2 7AGUnited KingdomManchesterGreater ManchesterM15 6SXUnited KingdomChorleyLancashirePR7 1NYUnited KingdomWiganLancashireWN6 9EWUnited KingdomLiverpoolMerseysideL1 9ADUnited KingdomLiverpoolMerseysideL22 0LGUnited KingdomCardiffSouth GlamorganCF1 3USUnited KingdomBirminghamWest MidlandsB15 2SQUnited KingdomUnited KingdomNovember 2011May 17, 2011November 2, 2011November 4, 2011December 10, 2014December 10, 2014December 11, 2014Therapeutic Area HeadBayer Consumer Care, Inc.Sore ThroatPharyngitisCommon ColdTonsillitisAspirinAcetaminophen