Trial Outcomes & Findings for Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu (NCT NCT01448057)

Results Overview

The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2. Range from 1 to 5 where 1 is excellent and 5 is bad : 1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

341 participants

Primary outcome timeframe

Day 2

Results posted on

2017-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets	Paracetamol Tablets Paracetamol (500 mg) tablets Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets
Overall Study STARTED	170	171
Overall Study COMPLETED	162	167
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets	Paracetamol Tablets Paracetamol (500 mg) tablets Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets
Overall Study Protocol Violation	3	2
Overall Study Lost to Follow-up	3	0
Overall Study Adverse Event	0	2
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=170 Participants Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets	Arm B n=171 Participants Paracetamol (500 mg) tablets Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets	Total n=341 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	170 Participants n=5 Participants	171 Participants n=7 Participants	341 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36 years STANDARD_DEVIATION 11.64 • n=5 Participants	34.5 years STANDARD_DEVIATION 11.76 • n=7 Participants	35.3 years STANDARD_DEVIATION 11.71 • n=5 Participants
Gender Female	122 Participants n=5 Participants	134 Participants n=7 Participants	256 Participants n=5 Participants
Gender Male	48 Participants n=5 Participants	37 Participants n=7 Participants	85 Participants n=5 Participants
Region of Enrollment Brazil	170 participants n=5 Participants	171 participants n=7 Participants	341 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 2

Population: In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm

The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2. Range from 1 to 5 where 1 is excellent and 5 is bad : 1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms

Outcome measures

Outcome measures
Measure	Arm A n=162 Participants Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets	Arm B n=170 Participants Paracetamol (500 mg) tablets Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets
Physician Global Evaluation of Effectiveness on Nasal Symptoms	1.9 score on a scale Standard Deviation 0.84	2.1 score on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Day 3

Population: In the combination product arm 11 subjects had missing assessment and 5 subject in the paracetamol arm

Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms

Outcome measures

Outcome measures
Measure	Arm A n=159 Participants Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets	Arm B n=166 Participants Paracetamol (500 mg) tablets Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets
Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms	169.2 mm Standard Deviation 231.14	225.3 mm Standard Deviation 262.59

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 77 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm A n=170 participants at risk Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets	Arm B n=171 participants at risk Paracetamol (500 mg) tablets Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets
Nervous system disorders somnolence	41.8% 71/170 • Number of events 71 • 3 days	21.6% 37/171 • Number of events 37 • 3 days
Gastrointestinal disorders Abdominal pain	3.5% 6/170 • Number of events 6 • 3 days	1.2% 2/171 • Number of events 2 • 3 days

Additional Information

Director Clinical research Respiratory

Novartis consumer Health a GSK Consumer Healtcare company

Phone: (1) 5512065988

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Preliminary agreement between Novartis Consumer Health and the investigator
Publication restrictions are in place

Restriction type: OTHER