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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 Baseline

Ratio 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 1

Ratio 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

Page last updated: August 23, 2015

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