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NCT01199497
Multicenter Clinical Trial Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms in Subjects Above 12 Years of Age, Suffering From Non-productive Cough and Acute Rhinitis.
Phase 3 trial testing Group 1 in Nasal Congestion. Withdrawn.
1 August 2012
Quick facts
| Lead sponsor | Ache Laboratorios Farmaceuticos S.A. |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Start date | 1 August 2011 |
| Primary completion | 1 August 2012 |
| Estimated completion | 1 January 2013 |
Drugs / interventions tested
- Group 1
- Group 2
Conditions studied
- Nasal Congestion — all drugs for Nasal Congestion →
- Cough — all drugs for Cough →
Sponsor
Ache Laboratorios Farmaceuticos S.A. — full company profile →
Who can join
12 and older, any sex, with Nasal Congestion or Cough. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Primary efficacy criteria
Time frame: baseline and week 24
The changes of lung function parameter: pre-bronchodilator forced expiratory volume in first second (FEV1) including baseline and 24th week.
Sponsor's own description
Multicenter clinical trial, phase III, controlled by active medicine, double-blind, randomized, enroll 208 subjects, above 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01199497
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Ache Laboratorios Farmaceuticos S.A. trials
Trials by the same sponsor.
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- NCT02582177 — Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis · Phase 3 · completed
- NCT02798367 — Melatonin 3mg and 5mg Compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the Treatment of Insomnia · Phase 2, PHASE3 · unknown
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- NCT00967759 — Study Comparing 3 Formulations to Evaluate the Efficacy and Safety of the Inflammatory Symptoms of the Upper Respiratory · Phase 3 · withdrawn
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 NCT01199497 (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 Ache Laboratorios Farmaceuticos S.A.
- Last refreshed: 11 July 2017
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/NCT01199497.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing