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OpenTrials
Completed

NCT Number: NCT01532882

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr Jean-Jérôme GUEX

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Patient treated by venotonic treatments or vascular protectants or assimilated dietary supplements or homeopathic treatments or diuretics within 15 days prior inclusion,
  • 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),
  • Patient treated by any analgesic within 7 days prior inclusion,
  • Patient treated by an anti-inflammatory treatment within 7 days prior inclusion,
  • 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 with a history of venous thromboses or thrombo-embolic diseases within the last 6 months before inclusion,
  • Patient treated with analgesics or anti-inflammatory treatments used as analgesics within 4 weeks prior inclusion
  • 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 ),

Treatment and study plan

Diosmin

Drug

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

Placebo

Drug

tablet, PO, 1 per day during 28 days

Primary outcomes

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

    Time frame: baseline and after 28 days

Secondary outcomes

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

    Time frame: 28 days

  2. - Daily VAS score for Response rate

    Time frame: 28 days

  3. - Daily VAS score for Time to response

    Time frame: 28 days

  4. - Score of Quality of life questionnaire (SQOR-V)

    Time frame: Between baseline and 28 days

  5. - Patient's and physician's global satisfaction score

    Time frame: At 28 days

  6. Adverse Events (numbers and frequency)

    Time frame: 28 days

  7. - Unusual intakes of analgesic treatments (rate of patients)

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Laboratoire Innotech International

Industry

Registry information

Official study 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

Acronym: EDEN

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2012
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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