Clinical Non-inferiority Study Between Diosmin 600mg & Diosmin + Hesperidin in Symptomatic Chronic Venous Insufficiency

NCT03471910 | Completed Phase 4

• 1 other identifier: DIVC-01-12-17
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical non-inferiority study between Diosmin 600 mg tablets and Diosmin 900 mg + Hesperidin 100 mg tablets in symptomatic chronic venous insufficiency after 6 months of treatment. Prospective, single-blind, randomized study in parallel groups (total patient population 120, 60 subjects per treatment group), with a total of 4 clinical assessment at months 0, 2, 4, and 6 of treatment.

Conditions

Venous Insufficiency

Keywords

Chronic venous insufficiency; Diosmin; Hesperidin

Outcome Measures

Primary Outcomes (1)

• Change in VAS symptom scores

  Change between the 100mm visual analog scale (VAS) symptoms (from 0mm \[absence of venous symptoms\] to 100mm \[maximal intensity of venous symptoms\] scores at month 0 (pretreatment) and month 6 / end of study visit (early withdrawal).

  From pretreatment (month 0) until month 6 of the 6-month treatment period

Secondary Outcomes (5)

• Efficacy: Evolution of VAS score at each visit

  From pretreatment (month 0) until month 6 of the 6-month treatment period

• Efficacy: Patient global satisfaction at each visit

  From pretreatment (month 0) until month 6 of the 6-month treatment period

• Oral acceptability

  From pretreatment (month 0) until month 6 of the 6-month treatment period

• Tolerance: Number of related adverse events during the study

  Throughout the 6-month treatment period

• Efficacy: Investigator's global satisfaction at each visit

  From pretreatment (month 0) until month 6 of the 6-month treatment period

Study Arms (2)

Diosmin

EXPERIMENTAL

Diosmin 600mg, one tablet once daily

Drug: Diosmin

Diosmin + Hesperidin

ACTIVE COMPARATOR

Diosmin 900mg + Hesperidin 100mg, one tablet once daily

Drug: Diosmin / Hesperidin

Interventions

Diosmin DRUG

Diosmin 600mg tablet, once daily

Diosmin

Diosmin / Hesperidin DRUG

Diosmin 900 mg / Hesperidin 100mg tablet, once daily

Diosmin + Hesperidin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders \>18 years old
• Patient presenting a C0 to C3 venous disease grade of the lower limbs, according to the clinical component of the CEAP classification,
• Clinical symptoms of chronic venous insufficiency of the lower limbs as defined by a VAS of 100 mm rated by the patient between 20 mm and 60 mm on the most symptomatic leg. The VAS is a global evaluation of the following symptoms: Heavy legs, Painful legs, Tired legs, Sensation of swelling and / or tension in the legs.
• Premenopausal female subjects not pregnant or breastfeeding, in use of reliable contraceptive
• Subject has read, understood, dated and signed the informed consent form

You may not qualify if:

• Premenopausal women who are pregnant, breastfeeding or who do not wish to use contraception during the study period
• Known allergy or hypersensitivity to any component of the study drug
• Known clinically significant laboratory alterations
• CEAP levels 4, 5 \& 6
• Patient with venous disease requiring surgery / chemical endovenous sclerotherapy
• Patient suffering from a painful pathology other than the venous pain in the lower limbs
• Patient with alteration of general condition incompatible with his / her participation in the trial
• Patient wishing to be pregnant in the 6 following months

Sponsors & Collaborators

• Fundação Educacional Serra dos Órgãos: lead

Study Sites (1)

Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, 25964004, Brazil

Location

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Diosmin; Hesperidin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavanones; Glycosides; Carbohydrates

Study Officials

• Marcio Steinbruch, MD

  Hospital Albert Einstein

  PRINCIPAL INVESTIGATOR

• Renato Kaufman, MD

  Universidade Estadual do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 21, 2018
• Study Start: June 20, 2017
• Primary Completion: March 20, 2018
• Study Completion: April 30, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)