Trial record 10 of 13 for:
Open Studies | "Hemorrhoids"
Efficacy and Tolerability of the Use of Varicell Compared With Daflon
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Vidfarma Indústria de Medicamentos Ltda..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Vidfarma Indústria de Medicamentos Ltda.
Information provided by:
Vidfarma Indústria de Medicamentos Ltda.
ClinicalTrials.gov Identifier:
NCT01321619
First received: March 15, 2011
Last updated: June 13, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Venous Insufficiency Hemorrhoids |
Drug: Daflon Drug: Varicell placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Vidfarma Indústria de Medicamentos Ltda.:
Primary Outcome Measures:
- Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Evaluate the efficacy of varicell compared with Daflon in the symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome.
Secondary Outcome Measures:
- Study to evaluate the efficacy and tolerability of the Use of Varicell Compared with Daflon. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Evaluate the tolerability of the use of Varicell when used for symptomatic treatment of chronic venous insufficiency and / or hemorrhoidal syndrome compared with Daflon.
| Estimated Enrollment: | 102 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Varicell
Drug A(Varicell) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
|
Drug: Daflon
Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
Other Name: Diosmin
|
|
Experimental: Placebo daflon (Drug D)
Drug D (Placebo Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
|
Drug: Varicell placebo
Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
Other Names:
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321619
Contacts
| Contact: Marcelo Calil, Investigator | 55 11 5549-6488 | mcburihan@osite.com.br |
| Contact: Mônica Gonçalves, Coordenator | 55 11 2070-6238 | monica_monica0001@hotmail.com |
Locations
| Brazil | |
| Santa Marcelina Hospital | Not yet recruiting |
| São Paulo, Brazil, 05016-081 | |
| Contact: Marcelo Calil, Investigator 55 11 2070-6238 mcburihan@osite.com.br | |
| Contact: Mônica Gonçalves, Coordenator 55 11 2070-6238 monica_monica0001@hotmail.com | |
| Sub-Investigator: Walter Campos Junior, Investigator | |
| Sub-Investigator: Laércio Robles, Investigator | |
| Sub-Investigator: Jacques Waisberg, Investigator | |
Sponsors and Collaborators
Vidfarma Indústria de Medicamentos Ltda.
Investigators
| Principal Investigator: | Jacques Waisberg, Investigator | ABC School of Medicine |
| Principal Investigator: | Walter Campos Júnior, Investigator | Edmundo Vasconcelos Hospital Teacher |
| Principal Investigator: | Laércio Robles, Investigator | Santa Marcelina Hospital |
More Information
No publications provided
| Responsible Party: | Vidfarma Indústria de Medicamentos Ltda., Industry |
| ClinicalTrials.gov Identifier: | NCT01321619 History of Changes |
| Other Study ID Numbers: | VID-VAR-01/11 |
| Study First Received: | March 15, 2011 |
| Last Updated: | June 13, 2011 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Vidfarma Indústria de Medicamentos Ltda.:
|
Chronic venous insufficiency Hemorrhoidal syndrome Varicell |
Additional relevant MeSH terms:
|
Hemorrhoids Venous Insufficiency Rectal Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013