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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01062360

Collaborator

(none)

1,016

Enrollment

Locations

Arms

16.7

Actual Duration (Months)

17.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Cold Pharyngitis	Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) Drug: Pseudoephedrine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1016 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 23, 2005

Actual Primary Completion Date :

May 14, 2007

Actual Study Completion Date :

May 14, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine 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.
Active Comparator: Arm 2	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) 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.
Active Comparator: Arm 3	Drug: Pseudoephedrine 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.
Placebo Comparator: Arm 4	Drug: Placebo 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
The results of an overall assessment of treatment by the subjects at 120 minutes post dose [120 minutes]
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) [Day 3]
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) [Day 3]
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) [Day 2 and Day 3]
Total amount of drug intake [Day 3]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	New York	New York	United States	11021
2	New York	New York	United States	11743
3	Alassio		Italy	17021
4	Albenga		Italy	17031
5	Arenzano		Italy	16011
6	Civitella Paganico		Italy	58048
7	Follonica		Italy	58022
8	Genova		Italy	16010
9	Genova		Italy	16125
10	Genova		Italy	16128
11	Genova		Italy	16129
12	Genova		Italy	16131
13	Genova		Italy	16137
14	Genova		Italy	16143
15	Genova		Italy	16149
16	Genova		Italy	16161
17	Genova		Italy	16162
18	Grosseto		Italy	58100
19	Grossetto		Italy	58100
20	Isola del Cantone		Italy	16017
21	Loano		Italy	17025
22	Masone		Italy	16010
23	Orbetello		Italy	58100
24	Pegli		Italy	16100
25	Quiliano		Italy	17047
26	Rivarolo		Italy	16150
27	Ronco Scrivia		Italy	16019
28	Sampierdarena		Italy	16151
29	Scansano		Italy	58054
30	Serra Ricco		Italy	16010
31	Varazze		Italy	17019
32	Ciechocin		Poland	87-408
33	Debowa Gora		Poland	96-116
34	Kattowitz		Poland	40-226
35	Kattowitz		Poland	40-520
36	Kattowitz		Poland	40-752
37	Krakau		Poland	31-215
38	Lodzi		Poland	93-105
39	Piaseczno		Poland	05-500
40	Skierniewice		Poland	96-100
41	Szczecin		Poland	71-140
42	Szczecin		Poland	71-502
43	Thorn		Poland	87-100
44	Warszawa		Poland	01-493
45	Warszawa		Poland	01-961
46	Warszawa		Poland	02-091
47	Warszawa		Poland	02-097
48	Warszawa		Poland	02-793
49	Warszawa		Poland	03-185
50	Zabrze		Poland	41-800
51	Bratislava		Slovakia	81107
52	Bratislava		Slovakia	84101
53	Bratislava		Slovakia	84104
54	Bratislava		Slovakia	84107
55	Bratislava		Slovakia	85101
56	Bratislava		Slovakia	85102
57	Bratislava		Slovakia	85105
58	Pezinok		Slovakia	90201
59	Stupava		Slovakia	90031