Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold

Cold Clinical Trial

Official title:

Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02735070
• Other study ID #: Coristina® d
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 18, 2016
• Last updated: April 6, 2016
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: Brainfarma Industria Química e Farmacêutica S/A
• Contact: Rosária Vastella
• Phone: 551130339742
• Email: rosariavastella[@]ttrial.com
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the non-inferiority of Coristina® d in the symptomatic treatment of the common cold compared to Resfenol® comparator.

Description:

Eligible patients must sign the informed consent form and they will be between 18 and 60 years old and common cold symptoms for no more than 72 hours.

It will be recruited for this study 366 patients, 183 patients per group. It is estimated that the total number of patients can be recruited in 4 to 6 months from the regulatory approval of the study.

The patient will stay in the study approximately 7 to 10 days (including screening visit / randomization, telephone contact in 3 to 5 days after randomization and final visit from 1 to 3 days after last dose).

Study medication (Coristina d and Resfenol) will be provided by the sponsor and will be appropriately labeled for the clinical study, containing the sponsor information, the trial identification, expiration date, batch and storage conditions

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 366
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Sign and date the informed consent form;

2. Age between 18 and 60 years old;

3. Symptoms of common cold not exceeding 72 hours must be present;

4. It will be considered symptoms of the common cold the presence of at least 2 of the 10 symptoms following: runny nose, sneezing, nasal congestion, headache, myalgia, throat discomfort or sore throat, hoarseness, cough or fever. Each of the symptoms listed above will receive a score by Likert scale (no symptom = 0, mild symptoms = 1, moderate symptoms = 2, intense symptoms = 3). The minimum total is 0 and maximum one is 30, which included patients with score higher or equal to 4 points.

Exclusion Criteria:

1. Presence of suggestive symptoms or prior diagnosis requiring regular and continuous treatment of allergic rhinitis or asthma in the last 2 years;

2. Chronic disease of any kind that is contraindicate the participation of the patient based on the opinion of investigator;

3. Hypersensitivity or contraindication to use of components of the study medications;

4. Pregnant or women of childbearing age without adequate contraception;

5. Use of other anti-influenza drugs programmed during the study or for the last 5 days;

6. Regular active smokers (more than 3 cigarettes a day);

7. Participation in another clinical study in less than one year (unless justified benefit by the investigator).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cold
• Common Cold

Intervention

Drug:
• Resfenol
Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.
• Coristina d
Patients included in the study will take the drugs 4 times a day, orally. Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Brainfarma Industria Química e Farmacêutica S/A	Pharmagenix, Techtrials Pesquisa e Tecnologia Ltda

References & Publications (24)

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Allan GM, Arroll B. Prevention and treatment of the common cold: making sense of the evidence. CMAJ. 2014 Feb 18;186(3):190-9. doi: 10.1503/cmaj.121442. Epub 2014 Jan 27. Review. — View Citation

Bantz EW, Dolen WK, Chadwick EW, Nelson HS. Chronic chlorpheniramine therapy: subsensitivity, drug metabolism, and compliance. Ann Allergy. 1987 Nov;59(5):341-6. — View Citation

Bertolazi NA. Tradução, adaptação cultural e validação de dois instrumentos de avalição do sono: escala de sonolência de Epworth e Índice de Qualidade de Sono de Pittsburgh. Tese de Mestrado apresentada a UFRGS em 2008. Porto Alegre - RS.

Brochura Coristina d - Hypermarcas AS.

Bula Coristina d (Nov 2012, atualizada em 2014).

Bula Resfenol - Laboratorios Kleyhertz (Data da bula: 21/05/2014).

Chow, Shao and Wang. Sample Size Calculations. In Clinical Research. Taylor & Francis, NY. (2003): Página 88.

Common Cold Collaborative Group, Robert M, Llorens M, García E, Luria X. Efficacy and tolerability of ebastine 10 mg plus pseudoephedrine 120 mg in the symptomatic relief of the common cold. Eur J Intern Med. 2004 Jul;15(4):242-247. — View Citation

De Sutter AI, van Driel ML, Kumar AA, Lesslar O, Skrt A. Oral antihistamine-decongestant-analgesic combinations for the common cold. Cochrane Database Syst Rev. 2012 Feb 15;2:CD004976. doi: 10.1002/14651858.CD004976.pub3. Review. — View Citation

Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother. 2007 Mar;41(3):381-90. Epub 2007 Jan 30. Review. — View Citation

Hengstmann JH, Goronzy J. Pharmacokinetics of 3H-phenylephrine in man. Eur J Clin Pharmacol. 1982;21(4):335-41. — View Citation

Micromedex novembro de 2015: ácido acetilsalicílico Micromedex novembro de 2015: dexclorfeniramina

Micromedex novembro de 2015: cafeína

Micromedex novembro de 2015: fenilefrina

Mizoguchi H, Wilson A, Jerdack GR, Hull JD, Goodale M, Grender JM, Tyler BA. Efficacy of a single evening dose of syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold — View Citation

Munch EP, Søborg M, Nørreslet TT, Mygind N. A comparative study of dexchlorpheniramine maleate sustained release tablets and budesonide nasal spray in seasonal allergic rhinitis. Allergy. 1983 Oct;38(7):517-24. — View Citation

Pastorello EA, Ortolani C, Gerosa S, Pravettoni V, Codecasa LR, Fugazza A, Zanussi C. Antihistaminic treatment of allergic rhinitis: a double-blind study with terfenadine versus dexchlorpheniramine. Pharmatherapeutica. 1987;5(2):69-75. — View Citation

Picon PD, Costa MB, da Veiga Picon R, Fendt LC, Suksteris ML, Saccilotto IC, Dornelles AD, Schmidt LF. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlle — View Citation

Pinto VF. Estudos clínicos de não-inferioridade: fundamentos e controvérsias. J Vasc Bras; 2010, v.9, n.3.

Product Information: phenylephrine hydrochloride injection solution, phenylephrine hydrochloride injection solution. PARENTA Pharmaceuticals, Inc, West Columbia, SC.

Product Information: Polaramine(R), dexchlorpheniramine maleate. Schering Corporation, Kenilworth, NJ, 1990.

Salisbury-Afshar E. Oral antihistamine/decongestant/analgesic combinations for the common cold. Am Fam Physician. 2012 Nov 1;86(9):812-3. Review. — View Citation

Simons FE, Simons KJ, Chung M, Yeh J. The comparative pharmacokinetics of H1-receptor antagonists. Ann Allergy. 1987 Dec;59(6 Pt 2):20-4. Erratum in: Ann Allergy 1988 Jun;60(6):540. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Evaluation from 1 to 3 days after last dose	The primary outcome will be the global evaluation from investigator to be done from 1 to 3 days after the last dose.	From 1 to 3 days after the last dose	Yes
Secondary	Likert Scale for symptons	It will be used a Likert Scale to evaluate the intensity of cold symptoms. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.	From the screening until 1 to 3 days after the last dose	Yes
Secondary	Sleep Questionnaire	It will be used a Sleep questionnaire to evaluate the sleep quality. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.	From the screening until 1 to 3 days after the last dose	Yes
Secondary	Daily Activities	It will be used a daily activities questionnaire to evaluate the physical and mental disposition on the routine daily activities. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.	From the screening until 1 to 3 days after the last dose	Yes
Secondary	Adverse Events	It will be evaluated and monitored the adverse events in order to assess the patient safety. It will be evaluated from randomization up to 1-3 days after last dose.	From the randomization until 1 to 3 days after the last dose	Yes

External Links

•   The Uppsala Monitoring Centre (UMC) - World Healthy Organization (WHO) causal categories