Phase 4
Completed N=53
The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.
Source: ClinicalTrials.gov NCT02246166 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Symptom Severity Assessment at 15 Minutes — 10.66; 10.64; -1.11; -1.13 Score on scale — p=0.9473
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptom Severity Assessment at 15 Minutes |
10.66; 10.64; -1.11; -1.13 | 0.9473 |
| PRIMARY Symptom Severity Assessment at 30 Minutes |
9.55; 9.74; -2.22; -2.03 | 0.7210 |
| PRIMARY Symptom Severity Assessment at 1 Hour |
8.73; 8.52; -3.04; -3.25 | 0.7445 |
| PRIMARY Symptom Severity Assessment at 2 Hours |
7.54; 7.31; -4.23; -4.46 | 0.7662 |
| PRIMARY Symptom Severity Assessment at 3 Hours |
6.80; 6.25; -4.97; -5.52 | 0.5208 |
| PRIMARY Symptom Severity Assessment at 4 Hours |
5.94; 5.82; -5.83; -5.95 | 0.8993 |
| SECONDARY Global Assessment of Treatment |
1; 2; 1; 3; 9; 3 | — |
| SECONDARY Sore Throat Severity Assessment |
-0.12; -0.28; -0.21; -0.29; -0.27; -0.29 | — |
| SECONDARY Headache Severity Assessment |
-0.17; -0.14; -0.31; -0.16; -0.47; -0.51 | — |
| SECONDARY Extremities Pain Severity Assessment |
-0.21; -0.10; -0.22; -0.19; -0.32; -0.32 | — |
| SECONDARY Nasal Congestion Severity Assessment |
-0.32; -0.31; -0.59; -0.60; -0.61; -0.68 | — |
| SECONDARY Runny Nose Severity Assessment |
-0.20; -0.18; -0.48; -0.32; -0.54; -0.61 | — |
| SECONDARY Sneezing Severity Assessment |
-0.10; -0.24; -0.25; -0.42; -0.50; -0.80 | — |
| SECONDARY Cough Severity Assessment |
-0.11; -0.06; -0.28; -0.25; -0.49; -0.33 | — |
| SECONDARY Body Temperature Reduction |
-0.02; 0.01; -0.03; -0.01; -0.04; 0.01 | — |
Eligibility Criteria
Inclusion Criteria
- Aged at least 18 years and less than 65 years
- Good general and mental health in the opinion of the investigator
- Participants diagnosed with a common cold or flu and must have the following symptoms of at least "moderate" in intensity (≥ 2) at the screening visit (baseline), with a minimum total symptom score of 6:
(i) At least one of pain symptoms: sore throat, headache, or extremities pain (ii) Mandatory: Nasal congestion (iii) At least one of catarrh symptoms: runny nose or sneezing
- Onset of first symptoms of cold must have occurred within 48 hours of screening.
Exclusion Criteria
- Pregnant or breast feeding women
- History of seasonal or perennial allergic rhinitis or acute, sub-chronic, or chronic cough due to any condition other than a common cold or flu, as determined by the investigator
- Concurrent illness or medical history that is contraindicated or cautioned about in the drug label
- Anatomical factors causing nasal congestion
- Fever with body temperature >38.5°C at baseline
- Have used any medication or herbal remedies to treat cold prior to screening (antibiotics in the last 7 days, antihistamines in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours)
- Any medication that has potential drug-drug interactions with study medications
- Known or suspected intolerance or hypersensitivity to the study materials
- Have a positive drug urine test or recent history (within the last 2 years) of alcohol or other substance abuse
Data sourced from ClinicalTrials.gov (NCT02246166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.