Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold

McNeil-PPC

Status and phase

Completed

Phase 4

Conditions

Nasal Congestion

Common Cold

Headache

Treatments

Drug: Pseudoephedrine/Paracetamol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00378144

A7801002

2006-000058-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety for a marketed sinus allergy product, Sinutab, in the treatment of nasal congestion and headache.

Full description

In response to a mandated requirement from the Belgium Medicines Agency - rising from the perforce switch of Sinutab® to a 2 active ingredients Pseudoephedrine+Paracetamol combination - we have made a commitment to demonstrate the safety and efficacy of Sinutab®.

In agreement with the Medicines Agency, an in-use Pharmacy-based study has been designed to demonstrate efficacy and safety of Sinutab® for the approved indications (symptomatic relief in the common cold).

This will be a randomized, double blind, placebo-controlled, comparative phase 4, multi-centre study in parallel groups between Sinutab and placebo. To study the drug in it's 'natural environment', community pharmacists will function as local investigators. Approximately 25 community pharmacists will be carefully selected, and only be taken into consideration if appropriate software programs are used in their pharmacy.

This implicates that the pharmacist has a medication record of his patients at his disposal which he will use to check the exclusion criteria. They will include subjects with early (≤ 48 hours) cold symptoms of blocked nose with headache. Subjects fulfilling the inclusion/exclusion criteria will be assigned to one of the two treatment groups, according to a computer-generated randomization list. A sufficient number of subjects will be randomized in the order of their enrolment, targeting at 300 evaluable subjects at the conclusion of study.

The following information will be collected every evening from subjects during 7 days: symptom assessment, compliance, adverse events and the ability to go to work or school.

Enrollment

469 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

age 18 years or more
reported cold symptoms beginning ≤ 48 hours prior to visit 1
scored ≥ 2 for each of nasal congestion and headache using the Modified Jackson Subject Evaluation Scale
willing and able to comply with scheduled visits, treatment plan, and other study procedures
evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial

Exclusion criteria

patients without an electronic medication record in the pharmacy
history of hypersensitivity to paracetamol or pseudoephedrine or lactose
fever more than 38.0°C (measured by pharmacist)
women in the fertile years who do not use a hormonal contraception or an intra-uterine device
use of concomitant drugs, medications or treatments that could interfere with the study drug
important intercurrent medical condition based on the available medication record of the patient. (cf. exclusion criterium 1)
history of nasal reconstructive surgery
alcohol and/or drug abuse within a 6-month period immediately preceding the screening visit
any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
participation in other clinical trials the last three months and during study participation.
employees of the clinical research centers, sponsor, the CRO's contracted for this study, or their immediate family members