Prostaglandin E1 in Outpatients With Intermittent Claudication
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stage II Peripheral Arterial Occlusive Disease; Intermittent Claudication Fontaine Stage II PAOD
Intervention: Alprostadil (Prostaglandin E1) (Drug); Pentoxifylline (Drug); Placebo to Pentoxifylline oral (Drug); Placebo to Alprostadil (Prostaglandin E1) intravenous (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Pharma Official(s) and/or principal investigator(s): UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
Summary
Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with
Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the
pain-free walking distance in patients with Intermittent Claudication.
Clinical Details
Official title: Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at BaselineRatio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline
Secondary outcome: Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1 Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2 Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1 Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1 Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2 Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1 Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects with Peripheral Arterial Occlusive Disease (PAOD) of the lower extremity in
Fontaine stage II
- Maximum walking distance on the treadmill (12 %, 3 km/h) between 30 and 150 m
- Stable Intermittent Claudication of at least 6 months standing with no acute
shortening of walking distance over the past 3 months
- Stenoses or occlusions below the Femoral Bifurcation (above-knee or below-knee type)
confirmed by duplex US or angiography
- Ankle/brachial index ≤ 0. 90 with a decrease in systolic ankle pressure of ≥ 10 %
after maximum loading (maximum walking distance on the treadmill at 3 km/h, 12 %)
- The patient is physically and mentally capable of participating in the trial
- Patient age > 40 years, male and female
- Patient is informed and given ample time and opportunity to think about her/his
participation and has given her/his written informed consent
- Patient is willing and able to comply with all trial requirements
Exclusion Criteria:
- Surgical or other interventional measures performed on the affected extremity and
Prostaglandin treatment within the 6 months immediately prior to the trial
- Rest pain and Necroses
- Systolic ankle pressure less than 50 mmHg
- Change in maximum walking distance during the one-week Run-in Phase of more than ± 25
% of Baseline
- Successful physical walking training within the 6 months immediately prior to the
trial
- Inflammatory vascular diseases
- Polyneuropathy in Diabetes Mellitus
- Diseases limiting walking distance (Arthrosis, inflammatory diseases of the joints,
neurological disease, diseases of the Vertebral Column, cardiopulmonary diseases)
- History of Pulmonary Oedema
- Myocardial infarction within the past 6 months
- Pregnancy or nursing
- Known hypersensitivity to any components of the trial medication or comparative drug
- Renal insufficiency, compensated retention (creatinine > 2. 0 mg/dL)
- Severe retinal Haemorrhage
- Massive Haemorrhage
- Known existing malignant diseases
- Vasoactive concomitant medication (e. g. Naftidrofuryl, Pentoxifylline, Buflomedil,
Cilostazol), or other Prostaglandins
- Untreated or uncontrolled Hypertension (systolic blood pressure ≥ 180 mmHg, diastolic
blood pressure ≥ 110 mmHg)
- Previous participation of the patient in the present trial
- Participation of the patient in a trial with the same objectives within the past 6
months, or is currently participating in another trial
- Illness of the patient due to alcohol or drug-abuse within the past 6 months
- Serious illness of the patient that the investigator considers to compromise his/her
participation in the trial
Locations and Contacts
Aachen, Germany
Bad Säckingen, Germany
Berlin, Germany
Bottrop, Germany
Dortmund, Germany
Dresden, Germany
Düsseldorf, Germany
Essen-Steele, Germany
Essen, Germany
Freiburg, Germany
Gaggenau, Germany
Görlitz, Germany
Hamburg, Germany
Hannover, Germany
Hattingen, Germany
Heidelberg, Germany
Homburg, Germany
Jena, Germany
Karlsbad-Lang Ensteinbach, Germany
Kassel, Germany
Krefeld, Germany
Köln, Germany
Leipzig, Germany
Lüneburg, Germany
Mannheim-Lindenhof, Germany
Mannheim, Germany
Mönchengladbach, Germany
München, Germany
Neuss, Germany
Nürnberg, Germany
Osnabrück, Germany
Papenburg, Germany
Regensburg, Germany
Seesen, Germany
Warendorf, Germany
Wuppertal, Germany
Additional Information
FDA Safety Alerts and Recalls
Starting date: April 2001
Last updated: October 17, 2014
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