A Phase 3 interventional study of Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets and Paracetamol (500 mg) tablets in Upper Respiratory Tract Infection, Nasal Congestion and Rhinorrhea, sponsored by Novartis. Completed at 6 sites in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 341 is above the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Use of other investigational drugs within 30 days or 10 half-lives before enrollment, whichever is longer.
Other protocol-defined inclusion/exclusion criteria may apply
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg) tablets
Drug: Paracetamol (500 mg) tablets
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg) tablets
Physician Global Evaluation of Effectiveness on Nasal Symptoms
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
Time frame: Day 2
Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms
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
Time frame: Day 3
| Milestone | Combination Product | Paracetamol Tablets |
|---|---|---|
| Started | 170 | 171 |
| Completed | 162 | 167 |
| Not completed | 8 | 4 |
| Withdrew: Protocol violation | 3 | 2 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Withdrawal by subject | 2 | 0 |
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
| score on a scale | Arm A | Arm B |
|---|---|---|
| Physician Global Evaluation of Effectiveness on Nasal Symptoms | 1.9 ± 0.84 | 2.1 ± 0.91 |
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
| mm | Arm A | Arm B |
|---|---|---|
| Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms | 169.2 ± 231.14 | 225.3 ± 262.59 |
Collected over 3 days. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A | — | 0/170 (0%) | 77/170 (45.3%) |
| Arm B | — | 0/171 (0%) | 39/171 (22.8%) |
| Event | Arm A | Arm B |
|---|---|---|
| somnolenceNervous system disorders | 71/170 | 37/171 |
| Abdominal painGastrointestinal disorders | 6/170 | 2/171 |
| Age, Categorical(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 170 | 171 | 341 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Arm A | Arm B | Total |
|---|---|---|---|
| Mean | 36 ± 11.64 | 34.5 ± 11.76 | 35.3 ± 11.71 |
| Gender(Participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Female | 122 | 134 | 256 |
| Male | 48 | 37 | 85 |
| Region of Enrollment(participants) | Arm A | Arm B | Total |
|---|---|---|---|
| Brazil | 170 | 171 | 341 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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