Clinical trial NCT01062360: Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
Official title: A Pivotal, Placebo Controlled, Phase III Study to Compare Efficacy and Tolerability of a Fixed Combination, Containing 500 mg ASA and 30 mg Pseudoephedrine, in Comparison to Its Single Components in Patients With Sore Throat and Nasal Congestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Cold
Pharyngitis
Keywords: Sore Throat
Upper Respiratory Tract Infections
Nasal Congestion
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 1016
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.


Eligibility criteria: Inclusion Criteria:- Male and female subjects between 18 and 65 years of age.- Onset of cold symptoms within 96 hours (4 days) before study participation.- Current complaint of at least moderate sore throat at baseline- Current complaint of at least moderate NC at baseline- History of other symptoms associated with URTI during the last 4 days before study participation.- Other findings of URTI, confirmed on the physical examination.- Agreement to comply with the study requirements.- Written informed consent prior to enrollment in the study Exclusion Criteria:- Pregnant or lactating females.- Uncontrolled chronic diseases.- History of hypersensitivity (allergic reaction) to ASA, any other nonsteroidal anti-inflammatory drugs (NSAIDs), or PSE.- Any disease which significantly compromises breathing or interferes with the subjects assessment of sore throat.- History of or active peptic ulcer.- Severe impaired hepatic function.- Severe impaired renal function.- Simultaneous intake of monoamine oxidase inhibitors.- Use of menthol containing tissues within 2 hours before first intake of study drug.- Intake of any menthol containing product within 4 hours before first intake of study drug.- Use of any local or systemic short acting cough and cold preparations within 6 hours before first intake of study drug.- Use of any local or systemic long acting cough and cold preparations within 12 hours before first intake of study drug.- Intake of any analgesic within 12 hours before first intake of study drug.- Intake or requirement of any prescription medication for the treatment of the current acute respiratory tract infection.- Current or previous intake of anticoagulants, corticoids, NSAIDs, methotrexate, or lithium.- Participation in another clinical trial within the last 30 days.

Primary outcomes:
measure: The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing
timeFrame: 2 hours
measure: The primary efficacy parameter for sore throat was SPID2 hours
timeFrame: 2 hours
Secondary outcomes:
measure: The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose
timeFrame: 15, 30, 60, 90, 120, 240, and 360 minutes
measure: The Nasal Congestion Score
timeFrame: 15, 30, 60, 90, 120, 240, and 360 minutes
measure: The Nasal Congestion Relief Score
timeFrame: 15, 30, 60, 90, 120, 240, and 360 minutes
measure: Sore throat pain relief
timeFrame: 15, 30, 60, 90, 120, 240, and 360 minutes
measure: The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose
timeFrame: 120 minutes
measure: The results of an overall assessment of treatment by the subjects at 120 minutes post dose
timeFrame: 120 minutes
measure: The results of an overall assessment of treatment by the subjects at the end of Day 3 after the first dose, or at the end of treatment (6 hours after last dose of study drug)
timeFrame: Day 3
measure: Nasal Congestion, Pain Intensity Difference and pain relief at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
timeFrame: Day 3
measure: The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
timeFrame: Day 2 and Day 3
measure: Total amount of drug intake
timeFrame: Day 3
Other outcomes:
Locations:
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Alassio
country: Italy
city: Albenga
country: Italy
city: Arenzano
country: Italy
city: Civitella Paganico
country: Italy
city: Follonica
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Genova
country: Italy
city: Grosseto
country: Italy
city: Grossetto
country: Italy
city: Isola del Cantone
country: Italy
city: Loano
country: Italy
city: Masone
country: Italy
city: Orbetello
country: Italy
city: Pegli
country: Italy
city: Quiliano
country: Italy
city: Rivarolo
country: Italy
city: Ronco Scrivia
country: Italy
city: Sampierdarena
country: Italy
city: Scansano
country: Italy
city: Serra Ricco
country: Italy
city: Varazze
country: Italy
city: Ciechocin
country: Poland
city: Debowa Gora
country: Poland
city: Kattowitz
country: Poland
city: Kattowitz
country: Poland
city: Kattowitz
country: Poland
city: Krakau
country: Poland
city: Lodzi
country: Poland
city: Piaseczno
country: Poland
city: Skierniewice
country: Poland
city: Szczecin
country: Poland
city: Szczecin
country: Poland
city: Thorn
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Zabrze
country: Poland
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Pezinok
country: Slovakia
city: Stupava
country: Slovakia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: