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NCT00940836
Phase III Clinical Trial - Efficacy and Safety Assessment of a Compound Acetaminophen, Chlorpheniramine and Phenylephrine Combination in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome in Adults
Phase 3 trial testing Resfenol in Common Cold in 146 participants. Status unknown.
1 November 2009
Quick facts
| Lead sponsor | Hospital de Clinicas de Porto Alegre |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 146 |
| Start date | 1 June 2009 |
| Primary completion | 1 November 2009 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Resfenol — full drug profile →
- Placebo
- Co interventional acetaminophen — full drug profile →
Conditions studied
- Common Cold — all drugs for Common Cold →
- Flu-like Syndrome — all drugs for Flu-like Syndrome →
Sponsor
Hospital de Clinicas de Porto Alegre
Who can join
Adults 18 to 60, any sex, with Common Cold or Flu-like Syndrome. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Symptom improval assessed by questionnaires concerning headache, muscle ache, rhinorrhea, nasal obstruction, sneezes, cough, sore or irritated throat, hoarseness and fever, rated by patient himself in a scale from 0 to 4, being 0-absence and 4-severe.
Time frame: Questionnaires were answered at baseline and 1st followup to the investigator and during treatment at every dose, 5 times a day, from day 1 to 3/4, through patient's diary.
Sponsor's own description
The aim of this study is to assess the efficacy and safety of an anti-cold preparation compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00940836
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Common Cold
Currently open trials in the same condition.
- NCT06724185 — Effects of LP28 on Immunity Enhancement in the Elderly · NA · recruiting
- NCT06531707 — Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine · Phase 3 · recruiting
- NCT06697886 — A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold · Phase 3 · recruiting
Other Hospital de Clinicas de Porto Alegre trials
Trials by the same sponsor.
- NCT07469722 — POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure · Phase 2, PHASE3 · not yet recruiting
- NCT07264179 — Tracheal Cuff Pressure and Postoperative Complications: A Prospective Observational Study. · not yet recruiting
- NCT07052058 — Triple-Blind Randomized Clinical Trial of Tocilizumab vs Placebo: Potential Use of an IL-6 Antagonist as an Adjuvant to · Phase 2 · not yet recruiting
- NCT06953128 — General Versus Regional Anesthesia in Peripheral Arterial Surgery · NA · not yet recruiting
- NCT06934707 — Meal Frequency and Glycemic Control in Individuals With Type 1 Diabetes · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00940836 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital de Clinicas de Porto Alegre
- Last refreshed: 15 July 2009
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00940836.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing