Intermittent Claudication Fontaine Stage II PAOD Clinical Trial
Official title:
Intravenous Prostaglandin E1 Treatment in Outpatients With Intermittent Claudication
| Verified date | May 2012 |
| Source | UCB Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 561 |
| Est. completion date | April 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| UCB Pharma |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) | No |
| Primary | 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. | From Baseline to the end of 6-months Follow-up (Period 3) | No |
| Primary | 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. | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) | No |
| Secondary | 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. | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) | No |
| Secondary | 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. | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) | No |
| Secondary | 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. | From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) | No |
| Secondary | 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. | From Baseline to the end of 4 weeks of Daily Treatment (Period 1) | No |
| Secondary | 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. | From Baseline to the end of 4 weeks of Interval Treatment (Period 2) | No |
| Secondary | 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. | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 4 weeks of Interval Treatment (Period 2) | No |
| Secondary | 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. | From Baseline to the end of 6-months Follow-up (Period 3) | No |
| Secondary | 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. | From the end of 4 weeks of Daily Treatment (Period 1) to the end of 6-months Follow-up (Period 3) | No |
| Secondary | 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. | From the end of 4 weeks of Interval Treatment (Period 2) to the end of 6-months Follow-up (Period 3) | No |
| Secondary | 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. |
From Baseline to the end of 4 weeks of Daily Treatment (Period 1) | No |
| Secondary | 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. |
From Baseline to the end of 6-months Follow-up (Period 3) | No |