A phase 3 clinical study to study the effects of different doses of phenylephrine hydrochloride in combination with paracetamol and/or ibuprofen, in people with blocked nose due to the common cold.

Phase 1

• Conditions: nasal congestion; MedDRA version: 18.0Level: PTClassification code 10028735Term: Nasal congestionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2015-002385-23-GB
• Lead Sponsor: AFT Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-16
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 275

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified