Clinical trial NCT01263925: Prostaglandin E1 in Outpatients With Intermittent Claudication
Official title: Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stage II Peripheral Arterial Occlusive Disease
Intermittent Claudication Fontaine Stage II PAOD
Keywords: Alprostadil
Prostaglandin E1
Prostavasin®
PAOD
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 561
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline
timeFrame: From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
measure: Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline
timeFrame: From Baseline to the end of 6-months Follow-up (Period 3)
measure: Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline
timeFrame: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Secondary outcomes:
measure: Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1
timeFrame: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)
measure: Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1
timeFrame: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)
measure: Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2
timeFrame: From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)
measure: Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline
timeFrame: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
measure: Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline
timeFrame: From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
measure: Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1
timeFrame: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)
measure: Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline
timeFrame: From Baseline to the end of 6-months Follow-up (Period 3)
measure: Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1
timeFrame: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)
measure: Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2
timeFrame: From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)
measure: Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1
timeFrame: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
measure: Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3
timeFrame: From Baseline to the end of 6-months Follow-up (Period 3)
Other outcomes:
Locations:
city: Aachen
country: Germany
city: Bad Säckingen
country: Germany
city: Berlin
country: Germany
city: Bottrop
country: Germany
city: Dortmund
country: Germany
city: Dresden
country: Germany
city: Düsseldorf
country: Germany
city: Essen-Steele
country: Germany
city: Essen
country: Germany
city: Freiburg
country: Germany
city: Gaggenau
country: Germany
city: Görlitz
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Hattingen
country: Germany
city: Heidelberg
country: Germany
city: Homburg
country: Germany
city: Jena
country: Germany
city: Karlsbad-Lang Ensteinbach
country: Germany
city: Kassel
country: Germany
city: Krefeld
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Lüneburg
country: Germany
city: Mannheim-Lindenhof
country: Germany
city: Mannheim
country: Germany
city: Mönchengladbach
country: Germany
city: München
country: Germany
city: Neuss
country: Germany
city: Nürnberg
country: Germany
city: Osnabrück
country: Germany
city: Papenburg
country: Germany
city: Regensburg
country: Germany
city: Seesen
country: Germany
city: Warendorf
country: Germany
city: Wuppertal
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: