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Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Common Cold; Pharyngitis

Intervention: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine (Drug); Acetylsalicylic Acid (Aspirin, BAYE4465) (Drug); Pseudoephedrine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing

The primary efficacy parameter for sore throat was SPID2 hours

Secondary outcome:

The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose

The Nasal Congestion Score

The Nasal Congestion Relief Score

Sore throat pain relief

The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose

The results of an overall assessment of treatment by the subjects at 120 minutes post dose

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)

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)

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)

Total amount of drug intake

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Alassio 17021, Italy

Albenga 17031, Italy

Arenzano 16011, Italy

Civitella Paganico 58048, Italy

Follonica 58022, Italy

Genova 16125, Italy

Genova 16162, Italy

Genova 16128, Italy

Genova 16129, Italy

Genova 16131, Italy

Genova 16137, Italy

Genova 16143, Italy

Genova 16149, Italy

Genova 16161, Italy

Genova 16010, Italy

Grosseto 58100, Italy

Grossetto 58100, Italy

Isola del Cantone 16017, Italy

Loano 17025, Italy

Masone 16010, Italy

Orbetello 58100, Italy

Pegli 16100, Italy

Quiliano 17047, Italy

Rivarolo 16150, Italy

Ronco Scrivia 16019, Italy

Sampierdarena 16151, Italy

Scansano 58054, Italy

Serra Ricco 16010, Italy

Varazze 17019, Italy

Ciechocin 87-408, Poland

Debowa Gora 96-116, Poland

Kattowitz 40-226, Poland

Kattowitz 40-520, Poland

Kattowitz 40-752, Poland

Krakau 31-215, Poland

Lodzi 93-105, Poland

Piaseczno 05-500, Poland

Skierniewice 96-100, Poland

Szczecin 71-140, Poland

Szczecin 71-502, Poland

Thorn 87-100, Poland

Warszawa 02-091, Poland

Warszawa 01-961, Poland

Warszawa 01-493, Poland

Warszawa 02-097, Poland

Warszawa 02-793, Poland

Warszawa 03-185, Poland

Zabrze 41-800, Poland

Bratislava 81107, Slovakia

Bratislava 84101, Slovakia

Bratislava 84104, Slovakia

Bratislava 85105, Slovakia

Bratislava 85101, Slovakia

Bratislava 85102, Slovakia

Bratislava 84107, Slovakia

Pezinok 90201, Slovakia

Stupava 90031, Slovakia

New York, New York 11021, United States

New York, New York 11743, United States

Additional Information

Click here and search for drug information provided by the FDA.

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Click here to find results for studies related to Bayer Healthcare products.

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Starting date: December 2005
Last updated: January 22, 2015

Page last updated: August 20, 2015

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