NCT00378144

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
469

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2006

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

1.2 years

First QC Date

September 5, 2006

Last Update Submit

July 6, 2012

Conditions

Common ColdHeadacheNasal Congestion

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the sum of nasal congestion and headache sign/symptom scores

    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

    7 days

  • Change from baseline in the mean individual sign/symptom score, including nasal congestion, headache, sore throat, and pressure around the eyes

    7 days

  • Number of lost days at work or school

    7 Days

  • Mean scores for: (a) interference with concentration; and (b) interference with sleep for days during treatment with study medication only

    7 days

  • Safety evaluation by adverse event recording

    7 days

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Pseudoephedrine/Paracetamol

Drug: Pseudoephedrine/Paracetamol

Interventions

Pseudoephedrine/ParacetamolDRUG

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 \[Paracetamol (500 mg) and Pseudoephedrine (30 mg)\]

Also known as: Sinutab
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • history of nasal reconstructive surgery
  • alcohol and/or drug abuse within a 6-month period immediately preceding the screening visit
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JJCPPW Investigational Site

Wilrijk, Antwerp, Belgium

Location

MeSH Terms

Conditions

Common ColdHeadacheNasal Obstruction

Interventions

PseudoephedrineAcetaminophenacetaminophen, phenylpropanolamine, phenyltoloxamine drug combination

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNose DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesPhenethylaminesEthylaminesAcetanilidesAnilidesAmidesAniline Compounds

Study Officials

  • Elisabeth A Kruse, PhD

    JJCPPW

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 19, 2006

Study Start

January 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

BE(1)