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

Bayer

Status and phase: Completed; Phase 3

Conditions: Pharyngitis; Common Cold

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01062360

2005-001720-36 (EudraCT Number)

11764

Details and patient eligibility

About

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.

Enrollment: 1,016 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,016 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

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

Arm 2

Active Comparator group

Treatment:

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Arm 3

Active Comparator group

Treatment:

Drug: Pseudoephedrine

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo