Efficacy and Tolerability of the Use of Varicell Compared With Daflon

Hemorrhoids Clinical Trial

Official title:

Study Clinical, Multicenter,Phase III,Prospective,Randomized,Comparative Double Blind/Double-dummy to Assess the Efficacy and Tolerability of the Use of Varicell in Reducing the Symptoms Caused by Chronic Venous Insufficiency and Hemorrhoidal Syndrome When Compared With Daflon

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01321619
• Other study ID #: VID-VAR-01/11
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 15, 2011
• Last updated: June 13, 2011
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: Vidfarma Indústria de Medicamentos Ltda.
• Contact: Marcelo Calil, Investigator
• Phone: 55 11 5549-6488
• Email: mcburihan[@]osite.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and tolerability of Varicell compared to Daflon, in reducing the symptoms caused by chronic venous insufficiency and hemorrhoidal syndrome.

Description:

To evaluate the efficacy of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.

To evaluate the tolerability of the use of Varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and hemorrhoidal syndrome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• For both groups

• Patients who consent to participate in the study by signing the Instrument of Consent.

• Patients of all ethnic groups, of both sexes and aged at least 18 years old and maximum 65 years old;

• Being for seven days without any medication or treatment related to the venous system.

• Patients able to make proper use of medication;

For Group V - Chronic Venous Insufficiency.

• Presence of at least two symptoms (pain, heaviness and discomfort) in the lower limbs with scores greater than 3 measured by visual analogue scale;

• Clinical diagnosis of varicose veins rating of 0 to 3 by CEAP;

In Group H - hemorrhoidal syndrome.

• Presence of at least two symptoms (pain in the anorectal evacuation to walk and / or at rest, feeling of anal discomfort (burning, itching, irritation) to evacuate to walk and / or at rest, bloating in the anorectal region, the presence and intensity of bleeding in the anorectal region, the presence and intensity of mucus in the anorectal region) with a score equal to or greater than 3 measured by visual analogue scale;

• Clinical Diagnosis of Hemorrhoids grade 1 and grade 2.

Exclusion Criteria:

Pregnant or lactating;

• Patients aged less than 18 years old or older than 65 years old;

• Patients with a history of hypersensitivity to any component of the formula;

• Use of medications phlebotonics in the last 7 days;

• previous venous surgery;

• Patients with renal and liver failure.

• Patients with gastritis or gastric ulcer;

• Patients with acute inflammatory diseases of the bowel, intestinal obstruction, appendicitis;

• Patients with ileus, stenosis, atony, undiagnosed abdominal symptoms, colonopathy inflammatory abdominal pain of unknown cause dehydration and loss of water and electrolytes and constipation;

• Patients with blood coagulation disorders;

• Any condition which in the opinion of the physician investigator is significant and can make the patient unsuitable for study or that might put you under additional risk.

Study Design

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Hemorrhoids
• Venous Insufficiency

Intervention

Drug:
• Daflon
Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
• Varicell placebo
Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.

Locations

Country	Name	City	State
Brazil	Santa Marcelina Hospital	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Vidfarma Indústria de Medicamentos Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.	Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome.	30 days	Yes
Secondary	Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon.	Evaluate the tolerability of the use of Varicell when used for symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome compared with Daflon.	30 days	Yes