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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innotech International
ClinicalTrials.gov Identifier:
NCT01532882
First received: February 10, 2012
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Venous Disease of Lower Limbs
 Drug: Diosmin
Drug: 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: Assessment of the Efficacy and Safety of Diosmin 600mg on Painful Symptomatology in Patients With Chronic Venous Disease of Lower Limbs: a Multicentric, Randomised, Double-blind, Placebo-controlled Trial in Parallel Groups

Further study details as provided by Innotech International:

Primary Outcome Measures:
  • Change of Visual analog Scale score for assessment of the painful venous symptomatology [ Time Frame: baseline and after 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Painful symptom intensity (daily VAS score) Area Under the Curve [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • - Daily VAS score for Response rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • - Daily VAS score for Time to response [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • - Score of Quality of life questionnaire (SQOR-V) [ Time Frame: Between baseline and 28 days ] [ Designated as safety issue: No ]
  • - Patient's and physician's global satisfaction score [ Time Frame: At 28 days ] [ Designated as safety issue: No ]
  • Adverse Events (numbers and frequency) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • - Unusual intakes of analgesic treatments (rate of patients) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 378
Study Start Date: January 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diosmin Drug: Diosmin
tablet, 600mg, PO, 1 tab per day during 28 days
Placebo Comparator: Placebo Drug: Placebo
tablet, PO, 1 per day during 28 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion,
  2. Patients who started treatments such as calcium inhibitors, beta-blockers, angiotensin converting enzyme inhibitors and/or vasodilators and/or vasoconstrictors within 28 days prior inclusion (for patients already taking this type of treatments, dosage should not have been changed in the 28 days prior inclusion and should not be planned to change in the course of the study),
  3. Patient treated by any analgesic within 7 days prior inclusion,
  4. Patient treated by an anti-inflammatory treatment within 7 days prior inclusion,
  5. Patient using elastic venous compression
  6. Patient presenting permanent oedema,
  7. Patients presenting venous skin changes,
  8. 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),
  9. Patient suffering from a pathology generating other pains than venous pains in the lower limbs,
  10. Patient with a history of lower limbs trauma responsible for sequel pains,
  11. Patient with a known deep venous reflux,
  12. Patient with a history of venous thromboses or thrombo-embolic diseases within the last 6 months before inclusion,
  13. Patient treated with analgesics or anti-inflammatory treatments used as analgesics within 4 weeks prior inclusion
  14. Patient having a known hypersensitivity to diosmin or one of the excipients
  15. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption ),
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532882

Locations
France
Dr Jean-Jérôme GUEX
Nice, France, 06000
Sponsors and Collaborators
Innotech International
Investigators
Principal Investigator: Jean-Jérôme GUEX, MD
  More Information

No publications provided

Responsible Party: Innotech International
ClinicalTrials.gov Identifier: NCT01532882     History of Changes
Other Study ID Numbers: DIO401-10
Study First Received: February 10, 2012
Last Updated: April 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 21, 2013