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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

Primary Purpose

Respiratory Tract Infections, Fever

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Acetylsalicylic acid (Aspirin, BAYE4465)

Paracetamol

Placebo

About this trial

This is an interventional treatment trial for Respiratory Tract Infections focused on measuring Upper Respiratory Tract Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Arm Label

Arm 2

Arm 3

Arm 4

Arm 5

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum temperature difference between baseline and the lowest measured temperature

Time to reach the maximum temperature difference

Intensity of Upper Respiratory Tract Infection symptoms

Safety - assessment of adverse events

Full Information

NCT ID

NCT01464944

First Posted

May 17, 2011

Last Updated

November 7, 2011

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01464944

Brief Title

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

Official Title

A Randomized, Double-blind, Double-dummy, Single-dose, Parallel Group, Multicenter Study to Compare the Antipyretic Efficacy of Acetylsalicy-lic Acid 500 mg and 1,000 mg (2 x 500 mg) and Paracetamol 500 mg and 1,000 mg (2 x 500 mg) With Placebo in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Tract Infections, Fever

Keywords

Upper Respiratory Tract Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

392 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 2

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Active Comparator

Arm Title

Arm 4

Arm Type

Active Comparator

Arm Title

Arm 5

Arm Type

Placebo Comparator

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Up to 4 hours post dose

Secondary Outcome Measure Information:

Title

Maximum temperature difference between baseline and the lowest measured temperature

Time Frame

Up to 4 hours post dose

Title

Time to reach the maximum temperature difference

Time Frame

Up to 4 hours post dose

Title

Intensity of Upper Respiratory Tract Infection symptoms

Time Frame

0, 2, 4, and 6 hours post dose

Title

Safety - assessment of adverse events

Time Frame

Up to 7 hours post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Moscow

ZIP/Postal Code

105064

Country

Russian Federation

City

Moscow

ZIP/Postal Code

107996

Country

Russian Federation

City

Moscow

ZIP/Postal Code

109386

Country

Russian Federation

City

Moscow

ZIP/Postal Code

125183

Country

Russian Federation

City

Moscow

ZIP/Postal Code

127015

Country

Russian Federation

City

Moscow

ZIP/Postal Code

127299

Country

Russian Federation

City

Kiev

ZIP/Postal Code

02232

Country

Ukraine

City

Kiev

ZIP/Postal Code

03049

Country

Ukraine

City

Lugansk

ZIP/Postal Code

91011

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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