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

NCT01062360 | Completed Phase 3

• 2 other identifiers: 117642005-001720-36
• Study Type: interventional
• Target: 1,016
• Locations: 4 countries
• Sites: 59

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.

Conditions

Common Cold; Pharyngitis

Keywords

Sore Throat; Upper Respiratory Tract Infections; Nasal Congestion

Outcome Measures

Primary Outcomes (2)

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

  2 hours

• The primary efficacy parameter for sore throat was SPID2 hours

  2 hours

Secondary Outcomes (10)

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

  15, 30, 60, 90, 120, 240, and 360 minutes

• The Nasal Congestion Score

  15, 30, 60, 90, 120, 240, and 360 minutes

• The Nasal Congestion Relief Score

  15, 30, 60, 90, 120, 240, and 360 minutes

• Sore throat pain relief

  15, 30, 60, 90, 120, 240, and 360 minutes

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

  120 minutes

Study Arms (4)

Arm 1

EXPERIMENTAL

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

Arm 2

ACTIVE COMPARATOR

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Arm 3

ACTIVE COMPARATOR

Drug: Pseudoephedrine

Arm 4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine DRUG

Single oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Arm 1

Acetylsalicylic Acid (Aspirin, BAYE4465) DRUG

Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Arm 2

Pseudoephedrine DRUG

Single oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Arm 3

Placebo DRUG

Single oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Arm 4

Eligibility Criteria

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (59)

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New York, New York, 11021, United States

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New York, New York, 11743, United States

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Alassio, 17021, Italy

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Albenga, 17031, Italy

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Arenzano, 16011, Italy

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Civitella Marittima, 58048, Italy

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Follonica, 58022, Italy

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Genova, 16010, Italy

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Genova, 16125, Italy

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Genova, 16128, Italy

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Genova, 16129, Italy

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Genova, 16131, Italy

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Genova, 16137, Italy

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Genova, 16143, Italy

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Genova, 16149, Italy

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Genova, 16161, Italy

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Genova, 16162, Italy

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Grosseto, 58100, Italy

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Grossetto, 58100, Italy

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Isola del Cantone, 16017, Italy

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Loano, 17025, Italy

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Masone, 16010, Italy

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Orbetello, 58100, Italy

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Pegli, 16100, Italy

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Quiliano, 17047, Italy

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Rivarolo, 16150, Italy

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Ronco Scrivia, 16019, Italy

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Sampierdarena, 16151, Italy

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Scansano, 58054, Italy

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Serra Riccò, 16010, Italy

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Varazze, 17019, Italy

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Ciechocin, 87-408, Poland

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Dębowa Góra, 96-116, Poland

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Katowice, 40-226, Poland

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Katowice, 40-520, Poland

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Katowice, 40-752, Poland

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Krakow, 31-215, Poland

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Lodz, 93-105, Poland

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Piaseczno, 05-500, Poland

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Skierniewice, 96-100, Poland

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Szczecin, 71-140, Poland

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Szczecin, 71-502, Poland

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Torun, 87-100, Poland

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Warsaw, 01-493, Poland

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Warsaw, 01-961, Poland

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Warsaw, 02-091, Poland

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Warsaw, 02-097, Poland

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Warsaw, 02-793, Poland

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Warsaw, 03-185, Poland

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Zabrze, 41-800, Poland

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Bratislava, 81107, Slovakia

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Bratislava, 84101, Slovakia

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Bratislava, 84104, Slovakia

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Bratislava, 84107, Slovakia

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Bratislava, 85101, Slovakia

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Bratislava, 85102, Slovakia

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Bratislava, 85105, Slovakia

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Pezinok, 90201, Slovakia

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Stupava, 90031, Slovakia

Location

Related Links

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

MeSH Terms

Conditions

Common Cold; Pharyngitis; Respiratory Tract Infections; Nasal Obstruction

Interventions

Aspirin; Pseudoephedrine

Condition Hierarchy (Ancestors)

Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: February 4, 2010
• Study Start: December 23, 2005
• Primary Completion: May 14, 2007
• Study Completion: May 14, 2007
• Last Updated: September 1, 2017

Record last verified: 2017-08

Locations

SL (9); PL (19); US (2); IT (29)