Efficacy and Safety of Diosmin 600mg Versus Placebo on Painful Symptomatology in Patients With Chronic Venous Disease of Lower Limbs

NCT01532882 | Completed Phase 3

• 1 other identifier: DIO401-10
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

Brief Summary

Diosmin has a well established use status in improvement of the symptoms of venolymphatic insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of capillary fragility. Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo, to establish its efficacy in the pain relief in Chronic Venous Disease (CVD). The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600 mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre, controlled, randomised, double blind, placebo-controlled, parallel-group study.

Conditions

Chronic Venous Disease of Lower Limbs

Outcome Measures

Primary Outcomes (1)

• Change of Visual analog Scale score for assessment of the painful venous symptomatology

  baseline and after 28 days

Secondary Outcomes (7)

• - Painful symptom intensity (daily VAS score) Area Under the Curve

  28 days

• - Daily VAS score for Response rate

  28 days

• - Daily VAS score for Time to response

  28 days

• - Score of Quality of life questionnaire (SQOR-V)

  Between baseline and 28 days

• - Patient's and physician's global satisfaction score

  At 28 days

Study Arms (2)

Diosmin

EXPERIMENTAL

Drug: Diosmin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Diosmin DRUG

tablet, 600mg, PO, 1 tab per day during 28 days

Diosmin

Placebo DRUG

tablet, PO, 1 per day during 28 days

Placebo

Eligibility Criteria

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

You may qualify if:

• Patient, man or woman, aged 18 and over,
• Patient presenting a C1s or C2s venous disease grade of the lower limbs
• Patient presenting a painful venous symptomatology in the lower limbs for at least 15 days.
• Patient suffering from venous symptomatology in one leg with a painful symptom intensity higher or equal to 30 mm (VAS= 100mm)

You may not qualify if:

• Patient using elastic venous compression
• Patient presenting permanent oedema,
• Patients presenting venous skin changes,
• Patient whose activity in the 4 following weeks (that is to say during the study) would be different from his/her usual activities (before the study),
• Patient suffering from a pathology generating other pains than venous pains in the lower limbs,
• Patient with a history of lower limbs trauma responsible for sequel pains,
• Patient with a known deep venous reflux,
• Patient having a known hypersensitivity to diosmin or one of the excipients
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption ),

Sponsors & Collaborators

• Laboratoire Innotech International: lead

Study Sites (1)

Dr Jean-Jérôme GUEX

Nice, 06000, France

Location

Related Publications (1)

• Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11(11):CD003229. doi: 10.1002/14651858.CD003229.pub4.

  PMID: 33141449 DERIVED

MeSH Terms

Interventions

Diosmin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jean-Jérôme GUEX, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2012
• First Posted: February 15, 2012
• Study Start: January 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

FR (1)