Effects of Two Doses of a Common Cold Treatment on Alertness

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Common Cold

Treatments: Drug: paracetamol; Drug: paracetamol + caffeine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01686646

RH01361

Details and patient eligibility

About

This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Participants with symptoms of cold < 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold.
• No history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in the 14 days prior to screening, no pregnancy, breastfeeding or participation in this trial, or another trial in the 30 days prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups

highest dose Paracetamol + caffeine

Active Comparator group

Description:

highest dose of Paracetamol and caffeine

Treatment:

Drug: paracetamol + caffeine

low-dose Paracetamol + caffeine

Active Comparator group

Description:

lowest dose of Paracetamol and caffeine

Treatment:

Drug: paracetamol + caffeine

high dose paracetamol

Active Comparator group

Description:

highest dose paracetamol

Treatment:

Drug: paracetamol

low dose paracetamol

Active Comparator group

Description:

lowest dose paracetamol

Treatment:

Drug: paracetamol