Antistax® in Patients With Chronic Venous Insufficiency

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02191280
• Collaborator: (none)
• Enrollment: 260
• Arms: 3

Study Details

Study Description

Brief Summary

Study to determine the efficacy and tolerability of two dose levels of Antistax relative to placebo in patients suffering from CVI grade I or incipient grade II

Condition or Disease	Intervention/Treatment	Phase
Venous Insufficiency	Drug: Antistax®, low dose; Drug: Antistax®, high dose; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Ability of Antistax® to Improve Chronic Venous Insufficiency (CVI) I and II in Male and Female Patients: a Dose Response Study
• Study Start Date: Apr 1, 1998
• Actual Primary Completion Date: Sep 1, 1998

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antistax®, low dose	Drug: Antistax®, low dose
Experimental: Antistax®, high dose	Drug: Antistax®, high dose
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Changes from baseline of limb volume [Baseline, day 84]

   determined by water displacement

Secondary Outcome Measures

1. Changes of limb volume [Baseline, days 42 and 98]

   determined by water displacement

2. Measurement of calf circumference [Baseline, days 42, 84 and 98]

   in centimeters

3. Measurement of ankle circumference [Baseline, days 42, 84 and 98]

   in centimeters

4. Assessment of subjective symptoms on a visual analogue scale (VAS) [Baseline, days 42, 84 and 98]

5. Assessment of global efficacy by patient on a 4-point verbal rating scale [days 42, 84 and 98]

6. Assessment of global efficacy by investigator on a 4-point verbal rating scale [days 42, 84 and 98]

7. Assessment of global tolerability by patient on a 4-point verbal rating scale [days 42, 84 and 98]

8. Assessment of global tolerability by investigator on a 4-point verbal rating scale [days 42, 84 and 98]

9. Number of patients with adverse events [up to 14 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female

• Between 25 and 75 years of age

• CVI I or CVI II (without expanded trophic disturbances)

• Willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

Concomitant disease(s) exclusion criteria:

• Decompensated cardiac insufficiency

• Edema not due to venous disease of the legs (e.g. latent cardiac insufficiency, renal insufficiency, lymph edema, etc)

• Peripheral arterial disease (ankle/arm pressure index < 0.9)

• Current acute phlebitis or thrombosis

• Renal insufficiency (Serum creatinine > 1.5 mg/dl)

• Liver disease (SGPT (ALAT) > 3x upper limit of normal)

• Other diseases: insulin-dependent diabetes mellitus, neuropathies, hyper- or hypocalcaemia, malignancies

• Anamnestic indications of diabetic microangiopathy or polyneuropathy

• Drug and/or alcohol abuse

• Severe climacteric complaints

• Immobility

• Avalvulia

• Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)

• State after pulmonary embolism

• Recognized hypersensitivity to the trial drug ingredients

• Current florid venous ulcus

• Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compressive treatment, phlebectomy, etc.

Previous treatment(s) exclusion criteria:

• Treatment with venous drugs within the last 4 weeks

• Treatment with laxatives which affect fluid or electrolyte balance within the last 8 days

• Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors or calcium antagonists within the last 8 days

• Changes in post-menopausal Hormone replacement within the last 2 months

Concomitant treatment/non-drug therapy exclusion criteria:

• Other venous drugs apart from the trial medication

• Compression therapy

• Venous surgery at the leg(s)

• Extensive use (on more than a total of 6 days during the entire trial) of laxatives which affect fluid or electrolyte balance

• Major surgery requiring full anesthesia

Other exclusion criteria:

• Previously studied under this protocol

• Participation in another clinical trial within the previous 90 days or during the present study

• Patients who have visited a sauna or had other thermal applications in the previous day before any visit

• Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)

• Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial

• Patients in a bad general health state according to the investigator's judgment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02191280
• Other Study ID Numbers: 1138.2
• First Posted: Jul 16, 2014
• Last Update Posted: Jul 16, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Venous Insufficiency; Quercetin

Study Results

No Results Posted as of Jul 16, 2014