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

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ClinicalTrials.gov Identifier: NCT03471910
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos

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.

Condition or disease Intervention/treatment Phase
Venous Insufficiency Drug: Diosmin Drug: Diosmin / Hesperidin Phase 4

Detailed Description:

The primary study objective is to demonstrate the clinical non inferiority of efficacy between Diosmin 600 mg tablets versus combination Diosmin 900 mg + Hesperidin 100 mg tablets in improving lower limb symptoms assessed by a 100 mm visual analogue scale (VAS) over 6 months among adult patients presenting chronic venous insufficiency of the lower limbs.

The secondary study objectives are to compare between Diosmin 600 mg tablets and combination Diosmin 900 mg + Hesperidin 100 mg tablets in terms of:

  • The oral acceptability,
  • The tolerability,
  • The global patient's satisfaction,
  • The global physician's satisfaction.

Clinical assessments will take place at the study center during the study visits at M0, M2, M4 and M6 including:

  • Efficacy on venous symptoms : The VAS of 100 mm is rated by the patient from "0" = Absence of venous symptoms up to "100" = Maximal intensity of the venous symptoms. The VAS is completed by the patient at the investigator's office. This VAS globally assesses the venous symptomatology of the most symptomatic leg : Heavy legs, Painful legs, Tired legs, Sensation of swelling and/or tension in the legs).
  • Acceptability : Easiness to swallow assessed by a VAS of 100 mm rated by the patient from "0" = Very easy to swallow, up to "10" = Very difficult to swallow
  • Patient's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
  • Investigator's global satisfaction related to the treatment efficacy : Four levels scale rated as following : bad, acceptable, good, and very good
  • Tolerability (related adverse events)
  • Compliance : Accountability of treatments returned by the patient

The primary endpoint will be the change between the VAS symptoms scores at M0 and M6 / end of study visit (early withdrawal). Secondary endpoints include assessments of efficacy, oral acceptability of study drug, and tolerance.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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: Single-blind, Randomized, Parallel Group Study
Actual Study Start Date : June 20, 2017
Actual Primary Completion Date : March 20, 2018
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
Experimental: Diosmin
Diosmin 600mg, one tablet once daily
Drug: Diosmin
Diosmin 600mg tablet, once daily

Active Comparator: Diosmin + Hesperidin
Diosmin 900mg + Hesperidin 100mg, one tablet once daily
Drug: Diosmin / Hesperidin
Diosmin 900 mg / Hesperidin 100mg tablet, once daily




Primary Outcome Measures :
  1. Change in VAS symptom scores [ Time Frame: From pretreatment (month 0) until month 6 of the 6-month treatment period ]
    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).


Secondary Outcome Measures :
  1. Efficacy: Evolution of VAS score at each visit [ Time Frame: From pretreatment (month 0) until month 6 of the 6-month treatment period ]
    Evolution of the 100mm VAS symptoms (from 0mm [absence of venous symptoms] to 100mm [maximal intensity of venous symptoms]) at each visit

  2. Efficacy: Patient global satisfaction at each visit [ Time Frame: From pretreatment (month 0) until month 6 of the 6-month treatment period ]
    Evaluation of the patient's global satisfaction at each visit on a four level scale of "bad", "acceptable", "good", and "very good"

  3. Oral acceptability [ Time Frame: From pretreatment (month 0) until month 6 of the 6-month treatment period ]
    Evaluation of the oral acceptability on a 100mm VAS (from 0mm - very easy to swallow to 100mm - very difficult to swallow) of the treatment at each visit

  4. Tolerance: Number of related adverse events during the study [ Time Frame: Throughout the 6-month treatment period ]
    Number of related adverse events during the study

  5. Efficacy: Investigator's global satisfaction at each visit [ Time Frame: From pretreatment (month 0) until month 6 of the 6-month treatment period ]
    Evaluation of the investigator's global satisfaction at each visit on a four level scale of "bad", "acceptable", "good", and "very good"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Treatment by compression stocking within the 2 months before inclusion
  • Treatment by venotonics within the 2 months before inclusion
  • 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 history of venous thrombosis or thromboembolic disease within the 6 months before inclusion
  • Patient with alteration of general condition incompatible with his / her participation in the trial
  • Patient wishing to be pregnant in the 6 following months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471910


Locations
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Brazil
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, RJ, Brazil, 25964004
Sponsors and Collaborators
Fundação Educacional Serra dos Órgãos
Investigators
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Principal Investigator: Marcio Steinbruch, MD Hospital Albert Einstein
Principal Investigator: Renato Kaufman, MD Universidade Estadual do Rio de Janeiro

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Responsible Party: Carlos Pereira Nunes, Professor of Internal Medicine, Fundação Educacional Serra dos Órgãos
ClinicalTrials.gov Identifier: NCT03471910     History of Changes
Other Study ID Numbers: DIVC-01-12-17
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos:
Chronic venous insufficiency
Diosmin
Hesperidin

Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases