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Trial record 1 of 1 for:    NCT01263925
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Prostaglandin E1 in Outpatients With Intermittent Claudication

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ClinicalTrials.gov Identifier: NCT01263925
Recruitment Status : Completed
First Posted : December 21, 2010
Results First Posted : June 29, 2012
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE December 17, 2010
First Posted Date  ICMJE December 21, 2010
Results First Submitted Date  ICMJE April 17, 2012
Results First Posted Date  ICMJE June 29, 2012
Last Update Posted Date October 27, 2014
Study Start Date  ICMJE April 2001
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
  • Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline [ Time Frame: From Baseline to the end of 4 weeks of Interval Treatment (Period 2) ]
    The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline [ Time Frame: From Baseline to the end of 6-months Follow-up (Period 3) ]
    The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline [ Time Frame: From Baseline to the end of 4 weeks of Daily Treatment (Period 1) ]
    The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 1 divided by the pain-free walking distance at Baseline with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
Original Primary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
  • Ratio of pain-free walking distance after 4 weeks of interval treatment (period 2) in comparison with the findings at baseline. [ Time Frame: From baseline to end of 4 weeks of interval treatment. ]
  • Ratio of pain-free walking distance at the end of the 6-month follow-up (period 3) in comparison with the findings at baseline. [ Time Frame: From baseline to end of 6-month follow-up. ]
  • Ratio of pain-free walking distance after 4 weeks of daily treatment (period 1) in comparison with the findings at baseline. [ Time Frame: From baseline to end of 4 weeks of daily treatment. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
  • Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1 [ Time Frame: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) ]
    The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 2 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1 [ Time Frame: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) ]
    The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 1 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2 [ Time Frame: From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) ]
    The ratio of pain-free walking distance was calculated by the pain-free walking distance after Period 3 divided by the pain-free walking distance after Period 2 with determination of pain-free walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline [ Time Frame: From Baseline to the end of 4 weeks of Daily Treatment (Period 1) ]
    The ratio of maximum walking distance was calculated by the maximum walking distance after Period 1 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline [ Time Frame: From Baseline to the end of 4 weeks of Interval Treatment (Period 2) ]
    The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1 [ Time Frame: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) ]
    The ratio of maximum walking distance was calculated by the maximum walking distance after Period 2 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline [ Time Frame: From Baseline to the end of 6-months Follow-up (Period 3) ]
    The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance at Baseline with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1 [ Time Frame: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) ]
    The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 1 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2 [ Time Frame: From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) ]
    The ratio of maximum walking distance was calculated by the maximum walking distance after Period 3 divided by the maximum walking distance after Period 2 with determination of maximum walking distances on the treadmill (12 % grade and 3 km/h). If a subject was not familiar with the treadmill, at least two test determinations were performed to accustom him/her to the treadmill. For all treadmill determinations the subject has been prevented from observing the treadmill display of the walking distance achieved.
  • Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 1 [ Time Frame: From Baseline to the end of 4 weeks of Daily Treatment (Period 1) ]
    Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor). Negative changes show a decrease from Baseline.
  • Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of Period 3 [ Time Frame: From Baseline to the end of 6-months Follow-up (Period 3) ]
    Scores for subscales were calculated by summing non-missing item scores ranging from 1 (not at all; best possible outcome) to 4 (extremely; worst possible outcome) divided by the number of non-missing items. Hence each subscale score ranges from 1 (best possible outcome) to 4 (worst possible outcome). For subscales 'Mood' and 'Treatment expectation' five items each had to be reversed in order. Additionally, subjects were asked to assess their general health and quality of life on an ordinal scale between 0 (very good) and 10 (very poor). Negative changes show a decrease from Baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
  • Ratio of pain-free walking distance after 4 weeks of interval treatment (period 2) in comparison with the findings after period 1. [ Time Frame: From end of 4 weeks of daily treatment to end of 4 weeks of interval treatment. ]
  • Ratio of pain-free walking distance at the end of the 6-month follow-up (period 3) in comparison with the findings after period 1. [ Time Frame: From end of 4 weeks of daily treatment to end of 6-month follow-up. ]
  • Ratio of pain-free walking distance at the end of the 6-month follow-up (period 3) in comparison with the findings after period 2. [ Time Frame: From end of 4 weeks of interval treatment to end of 6-month follow-up. ]
  • Ratio maximum walking distance after period 1 in comparison with baseline. [ Time Frame: From baseline to end of 4 weeks of daily treatment. ]
  • Ratio maximum walking distance after period 2 in comparison with baseline. [ Time Frame: From baseline to end of 4 weeks of interval treatment. ]
  • Ratio maximum walking distance after period 2 in comparison with findings after period 1. [ Time Frame: From end of 4 weeks of daily treatment to end of 4 weeks of interval treatment. ]
  • Ratio of maximum walking distance after 6-month of follow-up (period 3) in comparison with baseline [ Time Frame: From baseline to end of 6-month follow-up. ]
  • Ratio of maximum walking distance after 6-month of follow-up (period 3) in comparison with post-period 1 findings. [ Time Frame: From end of 4 weeks of daily treatment to end of 6-month follow-up. ]
  • Ratio of maximum walking distance after 6-month of follow-up (period 3) in comparison with post-period 2 findings. [ Time Frame: From end of 4 weeks of interval treatment to end of 6-month follow-up. ]
  • Changes in quality of life (as measured with the PAVK 86 questionnaire) after 4 weeks of daily treatment (period 1). [ Time Frame: From baseline to end of 4 weeks of daily treatment. ]
  • Changes in quality of life (as measured with the PAVK 86 questionnaire) after 6-month follow-up (period 3). [ Time Frame: From baseline to end of 6-month follow-up. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostaglandin E1 in Outpatients With Intermittent Claudication
Official Title  ICMJE Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage II Peripheral Arterial Occlusive Disease
  • Intermittent Claudication Fontaine Stage II PAOD
Intervention  ICMJE
  • Drug: 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.

    Other Name: Prostavasin
  • 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.

    Other Name: Trental®
  • 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.

  • 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.

Study Arms  ICMJE
  • Experimental: Alprostadil
    Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral
    Interventions:
    • Drug: Alprostadil (Prostaglandin E1)
    • Drug: Placebo to Pentoxifylline oral
  • Active Comparator: Pentoxifylline
    Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous
    Interventions:
    • Drug: Pentoxifylline
    • Drug: Placebo to Alprostadil (Prostaglandin E1) intravenous
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2010)
561
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01263925
Other Study ID Numbers  ICMJE SP0580
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP