Placebo and Active Controlled Study to Compare the Antipyretic Efficacy of Aspirin® in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin

NCT01464944 | Completed Phase 4

• 1 other identifier: 11202
• Study Type: interventional
• Target: 392
• Locations: 2 countries
• Sites: 9

Brief Summary

This study is addressed to patients suffering from an acute febrile upper respiratory tract infection suspected to be of viral origin. The purpose of this study is to determine the antipyretic efficacy (reduction of fever by lowering the body temperature from a raised state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo (comparator medication without an active substance). Despite of its common use for fever treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin are sparse. Therefore, the purpose of this study is to collect such data.

Conditions

Respiratory Tract Infections; Fever

Keywords

Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.

  Up to 4 hours post dose

Secondary Outcomes (4)

• Maximum temperature difference between baseline and the lowest measured temperature

  Up to 4 hours post dose

• Time to reach the maximum temperature difference

  Up to 4 hours post dose

• Intensity of Upper Respiratory Tract Infection symptoms

  0, 2, 4, and 6 hours post dose

• Safety - assessment of adverse events

  Up to 7 hours post dose

Study Arms (5)

Arm 2

EXPERIMENTAL

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Arm 3

ACTIVE COMPARATOR

Drug: Paracetamol

Arm 4

ACTIVE COMPARATOR

Drug: Paracetamol

Arm 5

PLACEBO COMPARATOR

Drug: Placebo

Arm 1

EXPERIMENTAL

Drug: Acetylsalicylic acid (Aspirin, BAYE4465)

Interventions

Acetylsalicylic acid (Aspirin, BAYE4465) DRUG

Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol

Arm 1

Paracetamol DRUG

Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid

Arm 3

Placebo DRUG

2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose

Arm 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory male or female patients 18 to 65 years of age
• Acute uncomplicated febrile URTI suspected to be of viral origin and present not more than 5 days
• Symptoms of a viral URTI
• Oral temperature \>/= 38.5 °C to \</= 40°C

You may not qualify if:

• Patients with physical findings consistent with the diagnosis of pneumonia, otitis media, bacterial sinusitis or any other bacterial infection of the respiratory tract requiring antibiotics or other therapeutic intervention by a physician
• Current antibiotic treatment or pre-treatment with antibiotic agents during the last week
• History or presence of asthma or hypersensitivity to ASA, salicylates, paracetamol, or other non-steroidal anti-inflammatory drugs; peptic ulceration or gastric bleeding; hemorrhagic diathesis; hepatic and/or renal dysfunction; Gilbert's disease; Quincke's edema
• Any other acute or chronic disease which in the opinion f the investigator could interfere with the patient's health and well-being during the conduct of the study or which could interfere with the evaluation of data generated from this subject
• Any conditions possibly interfering with the gastro-intestinal absorption of the study medication
• Pregnant or lactating women. All women of childbearing age were to undergo a pregnancy test before start of the study

Sponsors & Collaborators

• Bayer: lead

Study Sites (9)

Unknown Facility

Moscow, 105064, Russia

Location

Unknown Facility

Moscow, 107996, Russia

Location

Unknown Facility

Moscow, 109386, Russia

Location

Unknown Facility

Moscow, 125183, Russia

Location

Unknown Facility

Moscow, 127015, Russia

Location

Unknown Facility

Moscow, 127299, Russia

Location

Unknown Facility

Kiev, 02232, Ukraine

Location

Unknown Facility

Kiev, 03049, Ukraine

Location

Unknown Facility

Luhansk, 91011, Ukraine

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Fever

Interventions

Aspirin; Acetaminophen

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, 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: April 1, 2004
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

UA (3); RU (6)