Common ColdPhase 4NCT00378144
Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold
A Phase 4 study testing Pseudoephedrine/Paracetamol in people with Common Cold and Headache, run by McNeil AB at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Cold, Headache, Nasal Congestion
- What is being tested?
- Pseudoephedrine/Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2007to Mar 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community Pharmacy Based Investigation in the Self-Medication Area Efficacy and Safety of Sinutab and Pseudoephedrine on Subjects With Nasal Congestion Accompanied by Headache in the Setting of a Common Cold
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.
Read the detailed 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.
- Conditions
- Common Cold, Headache, Nasal Congestion
- Being tested
- Pseudoephedrine/Paracetamol
- Medical subject headings
- Common Cold, Headache, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pseudoephedrine/ParacetamolDrug
Also called Sinutab
Fixed oral tablet doses, 2 tablets 3 times a day for 5 days with at least 4 hours between each treatment (morning-noon-evening) and last dose not later than 2 hours before bedtime [Paracetamol (500 mg) and Pseudoephedrine (30 mg)]
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pseudoephedrine/Paracetamol Receives: Drug: Pseudoephedrine/Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the sum of nasal congestion and headache sign/symptom scores
Measured: 7 days
Secondary outcomes (6)
Change from baseline in the mean MSC score over the treatment days. The MSC score is defined as the sum of nasal congestion, headache, sore throat, and pressure around the eyes sign/symptom scores
Measured: 7 days
Change from baseline in the mean individual sign/symptom score, including nasal congestion, headache, sore throat, and pressure around the eyes
Measured: 7 days
Number of lost days at work or school
Measured: 7 Days
Mean scores for: (a) interference with concentration; and (b) interference with sleep for days during treatment with study medication only
Measured: 7 days
Safety evaluation by adverse event recording
Measured: 7 days
Exploratory Endpoint: time to reach the first of two consecutive total Modified Jackson Subject Evaluation Scale (MJS) scores (defined as sum of 8 signs/symptoms) ≤ 1
Measured: Up to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startJan 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 469 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth A Kruse, PhD, Study director, JJCPPW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378144
- Sponsor's protocol ID
- A7801002
- Other IDs
- 2006-000058-35
- Status last verified
- Jul 2012
- First submitted
- 5 Sep 2006
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Pharmacy Based Investigation in the Self-Medication Area Efficacy and Safety of Sinutab and Pseudoephedrine on Subjects With Nasal Congestion Accompanied by Headache in the Setting of a Common Cold
- ClinicalTrials.gov ID
- NCT00378144
- Acronym / sponsor ID
- A7801002
- Conditions
- Common Cold, Headache, Nasal Congestion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 469 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 19 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pseudoephedrine/ParacetamolPseudoephedrine/Paracetamol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pseudoephedrine/ParacetamolAlso: SinutabFixed oral tablet doses, 2 tablets 3 times a day for 5 days with at least 4 hours between each treatment (morning-noon-evening) and last dose not later than 2 hours before bedtime [Paracetamol (500 mg) and Pseudoephedrine (30 mg)] | Drug | 1 |
Primary outcome
Change from baseline in the sum of nasal congestion and headache sign/symptom scores
Time frame: 7 days
6 secondary outcomes
Change from baseline in the mean MSC score over the treatment days. The MSC score is defined as the sum of nasal congestion, headache, sore throat, and pressure around the eyes sign/symptom scores
Time frame: 7 days
Change from baseline in the mean individual sign/symptom score, including nasal congestion, headache, sore throat, and pressure around the eyes
Time frame: 7 days
Number of lost days at work or school
Time frame: 7 Days
Mean scores for: (a) interference with concentration; and (b) interference with sleep for days during treatment with study medication only
Time frame: 7 days
Safety evaluation by adverse event recording
Time frame: 7 days
Exploratory Endpoint: time to reach the first of two consecutive total Modified Jackson Subject Evaluation Scale (MJS) scores (defined as sum of 8 signs/symptoms) ≤ 1
Time frame: Up to seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth A Kruse, PhD study director
JJCPPW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pseudoephedrine/Paracetamol in people with Common Cold and Headache, run by McNeil AB at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the sum of nasal congestion and headache sign/symptom scores (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.