Prostaglandin E1 in Outpatients With Intermittent Claudication

NCT ID: NCT01263925

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 561 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2011-04-30

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.

Conditions

Stage II Peripheral Arterial Occlusive Disease; Intermittent Claudication Fontaine Stage II PAOD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Alprostadil

Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral

Group Type: EXPERIMENTAL

Alprostadil (Prostaglandin E1)

Intervention Type: DRUG

4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours.

4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours.

Placebo to Pentoxifylline oral

Intervention Type: DRUG

4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets.

4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets.

Pentoxifylline

Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous

Group Type: ACTIVE_COMPARATOR

Pentoxifylline

Intervention Type: DRUG

4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Placebo to Alprostadil (Prostaglandin E1) intravenous

Intervention Type: DRUG

4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours.

4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours.

Interventions

Alprostadil (Prostaglandin E1)

4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours.

4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours.

Intervention Type: DRUG

Pentoxifylline

4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets.

Intervention Type: DRUG

Placebo to Pentoxifylline oral

4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets.

4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets.

Intervention Type: DRUG

Placebo to Alprostadil (Prostaglandin E1) intravenous

4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours.

4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours.

Intervention Type: DRUG

Other Intervention Names

Prostavasin; Trental®

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Aachen, , Germany

Bad Säckingen, , Germany

Berlin, , Germany

Bottrop, , Germany

Cologne, , Germany

Dortmund, , Germany

Dresden, , Germany

Düsseldorf, , Germany

Essen, , Germany

Essen-Steele, , Germany

Freiburg im Breisgau, , Germany

Gaggenau, , Germany

Görlitz, , Germany

Hamburg, , Germany

Hanover, , Germany

Hattingen, , Germany

Heidelberg, , Germany

Homburg, , Germany

Jena, , Germany

Karlsbad-Lang Ensteinbach, , Germany

Kassel, , Germany

Krefeld, , Germany

Leipzig, , Germany

Lüneburg, , Germany

Mannheim, , Germany

Mannheim-Lindenhof, , Germany

Mönchengladbach, , Germany

München, , Germany

Neuss, , Germany

Nuremberg, , Germany

Osnabrück, , Germany

Papenburg, , Germany

Regensburg, , Germany

Seesen, , Germany

Warendorf, , Germany

Wuppertal, , Germany

Countries

Germany

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

SP0580

Identifier Type: -

Identifier Source: org_study_id