Stage II Peripheral Arterial Occlusive DiseasePhase 3NCT01263925
Prostaglandin E1 in Outpatients With Intermittent Claudication
A Phase 3 study testing Alprostadil (Prostaglandin E1) and Pentoxifylline in people with Stage II Peripheral Arterial Occlusive Disease and Intermittent Claudication Fontaine Stage II PAOD, run by UCB Pharma at 36 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stage II Peripheral Arterial Occlusive Disease, Intermittent Claudication Fontaine Stage II PAOD
- What is being tested?
- Alprostadil (Prostaglandin E1) and Pentoxifylline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 561 participants
- Where
- 36 sitesGermany
- Study dates
- Apr 2001to Apr 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Germany36 sites
Study site
Aachen
Study site
Bad Säckingen
Study site
Berlin
Study site
Bottrop
Study site
Cologne
Study site
Dortmund
Study site
Dresden
Study site
Düsseldorf
Study site
Essen
Study site
Essen-Steele
Study site
Freiburg im Breisgau
Study site
Gaggenau
Study site
Görlitz
Study site
Hamburg
Study site
Hanover
Study site
Hattingen
Study site
Heidelberg
Study site
Homburg
Study site
Jena
Study site
Karlsbad-Lang Ensteinbach
Study site
Kassel
Study site
Krefeld
Study site
Leipzig
Study site
Lüneburg
Study site
Mannheim
Study site
Mannheim-Lindenhof
Study site
Mönchengladbach
Study site
München
Study site
Neuss
Study site
Nuremberg
Study site
Osnabrück
Study site
Papenburg
Study site
Regensburg
Study site
Seesen
Study site
Warendorf
Study site
Wuppertal
About this study
Official title: Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication
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
- Being tested
- Alprostadil (Prostaglandin E1), Pentoxifylline, Placebo to Pentoxifylline oral, Placebo to Alprostadil (Prostaglandin E1) intravenous
- Keywords
- Alprostadil, Prostaglandin E1, Prostavasin®, PAOD
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprostadil (Prostaglandin E1)Drug
Also called Prostavasin
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.
PentoxifyllineDrug
Also called Trental®
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 Pentoxifylline oralDrug
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.
Placebo to Alprostadil (Prostaglandin E1) intravenousDrug
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 group | Role | What they receive |
|---|---|---|
| Alprostadil | Experimental | Alprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral Receives: Drug: Alprostadil (Prostaglandin E1); Drug: Placebo to Pentoxifylline oral |
| Pentoxifylline | Active comparator | Pentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous Receives: Drug: Pentoxifylline; Drug: Placebo to Alprostadil (Prostaglandin E1) intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings at Baseline
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.
Measured: From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings at Baseline
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.
Measured: From Baseline to the end of 6-months Follow-up (Period 3)
Ratio of Pain-free Walking Distance After Period 1 in Comparison With the Findings at Baseline
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.
Measured: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Secondary outcomes (11)
Ratio of Pain-free Walking Distance After Period 2 in Comparison With the Findings After Period 1
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.
Measured: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 1
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.
Measured: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)
Ratio of Pain-free Walking Distance After Period 3 in Comparison With the Findings After Period 2
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.
Measured: From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)
Ratio of Maximum Walking Distance After Period 1 in Comparison With the Findings at Baseline
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.
Measured: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings at Baseline
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.
Measured: From Baseline to the end of 4 weeks of Interval Treatment (Period 2)
Ratio of Maximum Walking Distance After Period 2 in Comparison With the Findings After Period 1
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.
Measured: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2)
Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings at Baseline
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.
Measured: From Baseline to the end of 6-months Follow-up (Period 3)
Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 1
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.
Measured: From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3)
Ratio of Maximum Walking Distance After Period 3 in Comparison With the Findings After Period 2
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.
Measured: From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3)
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of 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.
Measured: From Baseline to the end of 4 weeks of Daily Treatment (Period 1)
Changes in Quality of Life (as Measured With the PAVK 86 Questionnaire) From Baseline to the End of 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.
Measured: From Baseline to the end of 6-months Follow-up (Period 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startApr 2001
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage II Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263925
- Sponsor's protocol ID
- SP0580
- Status last verified
- May 2012
- First submitted
- 17 Dec 2010
- Last updated
- 27 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT01263925
- Acronym / sponsor ID
- SP0580
- Conditions
- Stage II Peripheral Arterial Occlusive Disease, Intermittent Claudication Fontaine Stage II PAOD
- Keywords
- Alprostadil, Prostaglandin E1, Prostavasin®, PAOD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Posted 29 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprostadil | Experimental | Drug: Alprostadil (Prostaglandin E1), Drug: Placebo to Pentoxifylline oralAlprostadil (Prostaglandin E1) intravenous and matching Placebo to Pentoxifylline oral |
| Pentoxifylline | Active comparator | Drug: Pentoxifylline, Drug: Placebo to Alprostadil (Prostaglandin E1) intravenousPentoxifylline oral and matching Placebo to Alprostadil (Prostaglandin E1) intravenous |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 %)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alprostadil (Prostaglandin E1)Also: Prostavasin4-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. | Drug | Alprostadil |
| PentoxifyllineAlso: Trental®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. | Drug | Pentoxifylline |
| Placebo to Pentoxifylline oral4-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 | Alprostadil |
| Placebo to Alprostadil (Prostaglandin E1) intravenous4-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. | Drug | Pentoxifylline |
Primary outcome
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.
11 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alprostadil (Prostaglandin E1) and Pentoxifylline in people with Stage II Peripheral Arterial Occlusive Disease and Intermittent Claudication Fontaine Stage II PAOD, run by UCB Pharma at 36 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.