nasal congestion MedDRA version: 18.0 Level: PT Classification code 10028735 Term: Nasal congestion System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Maxiclear TM PE 3.0
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Paracetamol
Other descriptive name: PARACETAMOL
Concentration unit: mg/g milligram(s)/gram
Concentration
Sponsors
AFT Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Male and/or female = 18 years of age 2)Presents cold symptoms which began within 96 hours of the study entry 3)Has a minimum score of 2 from the list of the following URTI symptoms: runny nose, blocked nose, sore throat and cough 4)For females – must be sterile or using adequate contraception 5)Has a baseline NAR = 0.25 Pa/cm3/sec Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 275 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)Use of any nasal decongestant (systemic or topical) within the last 12 hours 2)Previous participation in this clinical trial 3)Is a member or relative of the study site staff 4)Consumption of alcohol within the last 6 hours 5)Use of menthol containing products within the last 6 hours 6)Has taken paracetamol or ibuprofen within the last 6 hours 7)Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, ibuprofen or phenylephrine hydrochloride 8)Has a baseline NAR < 0.25 Pa/cm3/sec 9)Has experienced any surgical complications or other issues that, in the opinion of the investigator, could compromise the safety of the subject if he or she continues into randomized treatment or could confound the results of the study. 10)Has any clinically significant unstable cardiac, respiratory, neurological, immunological, haematological, or renal disease or any other condition that, in the opinion of the investigator, could compromise the subject’s welfare, ability to communicate with the study staff, or otherwise contraindicate study participation. 11)Has a history or current diagnosis of a significant psychiatric disorder that, in the opinion of the investigator, would affect the subject’s ability to comply with the study requirements. 12)Has anatomical nasal obstruction or gross anatomical deformity, including moderately or severely deviated septum or the presence of nasal polyps. 13)Has a history of bacterial sinusitis diagnosed in the previous two weeks prior to participating in this trial. 14)Has any clinically significant finding at Screening that, in the opinion of the investigator, contraindicates study participation. 15)Previously participated in another clinical study within 30 days before Screening. 16)Has used antibiotics within 10 days prior to entry 17)Has used tricyclic antidepressants or monoamine oxidase inhibitors within the last 30 days 18)Cannot abstain from smoking during the whole duration of the trial 19)Females of childbearing potential not using adequate contraception. A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilisation. 20)Women that are lactating, or known to be pregnant or possibly pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the Area Under the Curve of Nasal Airflow Conductance between 0 and 4 hours after the first dose of study medication on day 1 (AUC NAC0-4), calculated by the trapezoidal rule. For the primary efficacy endpoint, between-treatment differences will be tested by means of a one-way analysis of covariance (ANCOVA) model with treatment as a factor and the corresponding baseline (Day1) value as a covariate. A missing NAR value at 3 hours will be imputed by linear interpolation and a missing 4-hour value will be imputed by carrying forward the value from the preceding time point. The objective of the study is to test whether MaxiclearTM PE 30 and Maxigesic® PE 2.5 provide effective nasal decongestive relief which is comparable with that achieved with Phenylephrine 12 mg (Sudafed® Blocked Nose). To address this objective both MaxiclearTM PE 30 and Maxigesic® PE 2.5 will be compared with the placebo group and with Phenylephrine 12 mg (Sudafed® Blocked Nose). The two pairwise comparisons with placebo will be tested using a two-tailed p-value <0.05. No adjustment of the type I error rate is made here as these are considered two separate hypotheses relating to two independent products. The pair-wise non-inferiority comparisons with phenylephrine 12 mg (Sudafed® Blocked Nose) will use a one-sided 95% non-inferiority limit of a 15% difference in the NAC (AUC0-4). For either MaxiclearTM PE 30 or Maxigesic® PE 2.5 to be declared non-inferior the one-tailed upper 95% limit of the difference (Phenylephrine 12 mg (Sudafed® Blocked Nose) minus comparator; with larger values indicating greater efficacy) in the NAC (AUC0-4) must be less than 15% of the mean AUC0-4 of Sudafed® PE. ;Timepoint(s) of evaluation of this end point: N/A;Main Objective: Efficacy Objective: To evaluate and compare the nasal airways resistance (conductance) of fixed dose combination products containing 500 mg paracetamol and 3 mg phenylephrine hydrochloride (Maxiclear | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Area Under the Curve of subjective nasal congestion measured on the VAS (0 = no congestion, 100 = complete congestion) over the first hour after dosing (AUC VAS0-1) •Peak subjective relief of nasal congestion, measured as peak difference in VAS score from baseline (mm) within the first 60 minutes of the first dose of study medication •Time (minutes) to peak subjective relief of nasal congestion within the first 60 minutes of the first dose of study medication As with the primary efficacy endpoint, between-treatment differences in the AUC and peak of subjective nasal congestion relief will be tested by means of one-way analysis of covariance (ANCOVA) model with treatment as a factor and the corresponding baseline (Day 1) value as a covariate. The time to peak subjective nasal congestion relief will be summarised using Kaplan-Meier curves and compared between groups using log-rank tests. Intermittent missing VAS values will be imputed by linear interpolation. A missing VAS value at 60-minutes will be imputed by carrying forward the value from the preceding time point. Exploratory Endpoints The Exploratory Endpoints of this study are: •Area Under the Curve of Nasal Airflow Conductance between 0 and 1 hour, 0 and 2 hours, and 0 and 3 hours after the first dose of study medication on Day 1 (AUC NAC0-1, AUC NAC0-2, AUC NAC0-3), calculated by the trapezoidal rule. •Area Under the Curve of subjective nasal congestion measured on the VAS (0 = no congestion, 100 = complete congestion) over the first 2, 3 and 4 hours after the first dose of study medication on Day 1 (AUC VAS0-2, AUC VAS0-3, AUC VAS0-4), calculated by the trapezoidal rule As with the primary and secondary efficacy endpoints (with the exception of time to peak subjective relief), the exploratory endpoints will be compared between randomized groups using an ANCOVA model with treatment as a factor and the corresponding baseline values as a covariate. Missing VAS values will be | — |
Countries
United Kingdom
Contacts
Public ContactIoana Stanescu
AFT Pharmaceuticals Ltd
Outcome results
None listed