Common Cold Clinical Trial
Official title:
A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain.
The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.
Status | Completed |
Enrollment | 833 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient in general good health with suspected viral upper respiratory tract infection (common cold) Exclusion Criteria: - < 18 years old |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of nasal congestion and relief of pain | 4 hours | No | |
Secondary | Area under the curve for nasal airflow conductance from baseline | 1h, 2h, 3h | No | |
Secondary | Sum of subjective nasal congestion intensity differences | 1h, 2h, 3h, 4h and 1, 2, 3 days | No | |
Secondary | Total subjective nasal congestion relief | 1h, 2h, 3h,4 h and 1, 2, 3 days | No | |
Secondary | Global assessment of nasal congestion | 3 days | No | |
Secondary | Global assessment of pain relief | 3 days | No | |
Secondary | Sum of pain intensity differences | 1h, 2h, 3h, 4h and 1, 2, 3 days | No | |
Secondary | Total pain relief | 1, 2, 3 days | No | |
Secondary | Adverse Event collection and physical examination | 3 days | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05269290 -
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections
|
Phase 3 | |
Completed |
NCT02451163 -
DBRCT on the Effect of Wheat Polysaccharides on Common Cold Infections in Elderly
|
Phase 2 | |
Completed |
NCT01944631 -
Iota-Carrageenan Nasal Spray in Common Cold
|
Phase 4 | |
Completed |
NCT01651715 -
Efficacy and Safety Study of Homeopathic Oral Antibodies to Treat Viral Upper Respiratory Tract Infections
|
Phase 1/Phase 2 | |
Completed |
NCT00778648 -
Encapsulated Juice Powder Concentrate for Preventing Common Cold Symptoms
|
N/A | |
Completed |
NCT00065715 -
Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo)
|
Phase 3 | |
Completed |
NCT00032500 -
Evaluation of Echinacea for the Common Cold
|
Phase 2 | |
Not yet recruiting |
NCT05070650 -
Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold
|
Phase 3 | |
Not yet recruiting |
NCT04073511 -
Herbal Medicine 'Eungyosan' and 'Samsoeum' for Common Cold
|
N/A | |
Completed |
NCT04144491 -
Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda
|
N/A | |
Completed |
NCT03189537 -
Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections
|
Phase 3 | |
Terminated |
NCT01964885 -
Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections
|
Phase 3 | |
Completed |
NCT01277081 -
Effect of Paracetamol on the Common Cold
|
Phase 2 | |
Completed |
NCT01728090 -
Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
|
Phase 4 | |
Completed |
NCT00405509 -
The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
|
N/A | |
Completed |
NCT01033526 -
Symptomatic Treatment of Common Cold Symptoms
|
Phase 4 | |
Completed |
NCT05556148 -
Otrivine: Quality of Life (QoL) Impact in a Real-World Setting
|
Phase 4 | |
Terminated |
NCT03339726 -
Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold
|
Phase 2 | |
Completed |
NCT01361399 -
Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold
|
Phase 3 | |
Recruiting |
NCT05244148 -
Two Seawater-based Formulations for Relief of Nasal Congestion in Paediatric Subjects
|
N/A |