A Phase 3 interventional study of BNS003 in Venous Insufficiency, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-08-08.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with swelling of calf and ankle due to disorder of leg venous reflux.
193 studies on the registry are indexed under Venous Insufficiency; 15 are open to participants now.
This study's enrollment of 180 is above the median of 60 across 142 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →Boehringer Ingelheim is the lead sponsor of 2,300 studies on the registry; 59 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
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Exclusion Criteria:
Drug: BNS003
Global improvement on a five point scale
The degree of improvement was evaluated according to change of severity of each symptom at the time of enrollment (baseline) and in Week 12 after initiation of dosing (or at discontinuation)
Time frame: week 12
Number of patients with adverse drug reactions
Time frame: up to week 12
Improvement per symptom on a five point scale
Time frame: 12 weeks
Change in circumference measurements of calf in centimetres
Time frame: baseline, 12 weeks
Change in circumference measurements of ankle in centimetres
Time frame: baseline, 12 weeks
Subject's impression on improvement on a five point scale
Time frame: baseline, 12 weeks
Number of patients with of adverse events
Time frame: up to 12 weeks
No study locations are listed for this record.
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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