Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001970-29 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Aptiv Solutions | INDUSTRY |
Not provided
Not provided
Not provided
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The study is to confirmatorily show a superior effect of Alprostadil compared to placebo on the rate of complete healing of ischemic necroses and ulcerations as well as on the frequency and height of major amputations in patients suffering from PAOD stage IV.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alprostadil | Experimental | Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. |
|
| Placebo | Placebo Comparator | Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprostadil | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment | The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point. | At 12 weeks after the end of study drug treatment |
| Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment | Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated. | At 24 weeks after the end of study drug treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment | The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point. | At 24 weeks after the end of study drug treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 404 | Pilsen | Czechia | ||||
| 414 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28189475 | Result | Lawall H, Pokrovsky A, Checinski P, Ratushnyuk A, Hamm G, Randerath O, Grieger F, Bentz JWG. Efficacy and Safety of Alprostadil in Patients with Peripheral Arterial Occlusive Disease Fontaine Stage IV: Results of a Placebo Controlled Randomised Multicentre Trial (ESPECIAL). Eur J Vasc Endovasc Surg. 2017 Apr;53(4):559-566. doi: 10.1016/j.ejvs.2016.12.035. Epub 2017 Feb 8. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Participant Flow refers to the Randomized Set (RS). RS consists of all subjects randomized into the study who have completed the study or terminated prematurely.
This study started to enroll subjects in March 2004 in order to end up with 840 enrolled subjects. The study was conducted using a two-stage group sequential adaptive design with possible sample size adjustment after the planned interim analysis, which was performed after stage 1. After the interim analysis subjects were included in stage 2.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Alprostadil | Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. Alprostadil: - Active Substance: Prostaglandin E1
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Other |
|
|
| Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment | Visit values of intensity of rest pain from a visual analogue scale, ranging from 0 mm (no pain) to 100 mm (maximum conceivable pain), had to be reported in the case of presence of rest pain only. If the leading question in regard to the presence of rest pain is answered with "No" and no visit value is specified, the visit value will be set to 0 for the analysis. | At 24 weeks after the end of study drug treatment |
| Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment | In case of two ulcers the worse ulcer status is analyzed. The categories of investigator assessment are: complete healing, decrease by ≥ 50 %, unchanged, increase by ≥ 50 %. | At 24 weeks after the end of study drug treatment |
| Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days) | The number of subjects who used analgesics are summarized for different time points/intervals during the course of the study. | During the course of the study (up to 196 days) |
| Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment | Systolic pressure at ankle level was measured at the Arteria tibialis posterior and the Arteria dorsalis pedis. Two individual series of measurements of arterial pressures per subject across the assessed visits were selected for the analysis. For the first analysis (worst change analysis) the series of measurements in the one artery which has the worst change from Baseline at the final measurement was used. For the second analysis (worst value analysis) the series of measurements which has the worst final post-Baseline measurement was used. The series relevant for the analyses was selected from the series for the affected leg or legs only. The selection is 1 out of up to 4 series available per subject. Series without Baseline value and series with at least 1 measurement of more than 150 mmHg were excluded from the selection process due to the suspicion of media sclerosis of the lower limb artery. | At 24 weeks after the end of study drug treatment |
| Minor Amputations at 24 Weeks After the End of Study Drug Treatment | Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated. The number of subjects with minor amputation prior to or at 24 weeks after the end of study drug treatment is presented below. | At 24 weeks after the end of study drug treatment |
| Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment | The number of subjects with revascularization prior to or at 24 weeks after the end of study drug treatment is presented below. | At 24 weeks after the end of study drug treatment |
| All-cause Mortality During the Course of the Study (up to 196 Days) | During the course of the study (up to 196 days) |
| Cardiovascular Mortality During the Course of the Study (up to 196 Days) | During the course of the study (up to 196 days) |
| Cardiovascular Morbidity During the Course of the Study (up to 196 Days) | Cardiovascular morbidity is presented as number of subjects with myocardial infarction and/or stroke during the course of the study. | During the course of the study (up to 196 days) |
| Ústí nad Labem |
| Czechia |
| 1 | Karlsbad | Germany |
| 502 | Aguascalientes | Mexico |
| 505 | Mérida | Mexico |
| 501 | Querétaro | Mexico |
| 306 | Bydgoszcz | Poland |
| 321 | Gmina Końskie | Poland |
| 320 | Krakow | Poland |
| 314 | Lublin | Poland |
| 315 | Lublin | Poland |
| 316 | Poznan | Poland |
| 317 | Poznan | Poland |
| 301 | Szczecin | Poland |
| 304 | Szczecin | Poland |
| 307 | Warsaw | Poland |
| 308 | Warsaw | Poland |
| 309 | Warsaw | Poland |
| 318 | Warsaw | Poland |
| 319 | Warsaw | Poland |
| 312 | Wroclaw | Poland |
| 322 | Zamość | Poland |
| 246 | Barnaul | Russia |
| 205 | Chelyabinsk | Russia |
| 244 | Chelyabinsk | Russia |
| 228 | Irkutsk | Russia |
| 242 | Kazan' | Russia |
| 227 | Kemerovo | Russia |
| 201 | Moscow | Russia |
| 202 | Moscow | Russia |
| 203 | Moscow | Russia |
| 209 | Moscow | Russia |
| 219 | Moscow | Russia |
| 220 | Moscow | Russia |
| 230 | Moscow | Russia |
| 248 | Moscow | Russia |
| 231 | Novosibirsk | Russia |
| 232 | Novosibirsk | Russia |
| 222 | Omsk | Russia |
| 217 | Petrozavodsk | Russia |
| 206 | Rostov-on-Don | Russia |
| 225 | Rostov-on-Don | Russia |
| 236 | Rostov-on-Don | Russia |
| 239 | Rostov-on-Don | Russia |
| 224 | Ryazan | Russia |
| 210 | Saint Petersburg | Russia |
| 212 | Saint Petersburg | Russia |
| 213 | Saint Petersburg | Russia |
| 214 | Saint Petersburg | Russia |
| 215 | Saint Petersburg | Russia |
| 216 | Saint Petersburg | Russia |
| 218 | Samara | Russia |
| 237 | Saratov | Russia |
| 243 | Tula | Russia |
| 234 | Tver' | Russia |
| 238 | Tyumen | Russia |
| 241 | Ufa | Russia |
| 240 | Volgograd | Russia |
| 221 | Yaroslavl | Russia |
| 223 | Yekaterinburg | Russia |
| 247 | Yekaterinburg | Russia |
| 112 | Dnipropetrovsk | Ukraine |
| 109 | Donetsk | Ukraine |
| 110 | Donetsk | Ukraine |
| 114 | Ivano-Frankivsk | Ukraine |
| 111 | Kharkiv | Ukraine |
| 101 | Kiev | Ukraine |
| 102 | Kiev | Ukraine |
| 103 | Kiev | Ukraine |
| 104 | Kiev | Ukraine |
| 105 | Kiev | Ukraine |
| 106 | Lviv | Ukraine |
| 118 | Odesa | Ukraine |
| 119 | Odesa | Ukraine |
| 113 | Uzhhorod | Ukraine |
| 116 | Vinnytsia | Ukraine |
| 107 | Zaporizhzhya | Ukraine |
| 108 | Zaporizhzhya | Ukraine |
| FG001 |
| Placebo |
Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. Placebo: - Active Substance: Lactose
|
| Randomized and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Safety Set including all randomized subjects who received at least one dose of trial medication. Subjects were analyzed according to the actual treatment received. 4 PBO subjects were treated with Alprostadil, 3 Alprostadil subjects were treated with PBO.1 PBO subject withdrew prior to start of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Alprostadil | Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. Alprostadil: - Active Substance: Prostaglandin E1
|
| BG001 | Placebo | Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. Placebo: - Active Substance: Lactose
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment | The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point. | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | Posted | Number | participants | At 12 weeks after the end of study drug treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment | Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated. | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | Posted | Number | participants | At 24 weeks after the end of study drug treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment | The assessment of ulcer area was collected per lesion with up to 2 lesions per subject (both legs could be affected). In the analysis a subject is only considered completely healed at a time point, if all ischemic lesions are reported as completely healed at that time point. | Of the 838 subjects in the Full Analysis Set (FAS), 568 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | Posted | Number | participants | At 24 weeks after the end of study drug treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment | Visit values of intensity of rest pain from a visual analogue scale, ranging from 0 mm (no pain) to 100 mm (maximum conceivable pain), had to be reported in the case of presence of rest pain only. If the leading question in regard to the presence of rest pain is answered with "No" and no visit value is specified, the visit value will be set to 0 for the analysis. | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | Posted | Mean | Standard Deviation | millimeters (mm) | At 24 weeks after the end of study drug treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment | In case of two ulcers the worse ulcer status is analyzed. The categories of investigator assessment are: complete healing, decrease by ≥ 50 %, unchanged, increase by ≥ 50 %. | Of the 838 subjects in the Full Analysis Set (FAS), 465 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | Posted | Number | participants | At 24 weeks after the end of study drug treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days) | The number of subjects who used analgesics are summarized for different time points/intervals during the course of the study. | Full Analysis Set (FAS) consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | Posted | Number | participants | During the course of the study (up to 196 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment | Systolic pressure at ankle level was measured at the Arteria tibialis posterior and the Arteria dorsalis pedis. Two individual series of measurements of arterial pressures per subject across the assessed visits were selected for the analysis. For the first analysis (worst change analysis) the series of measurements in the one artery which has the worst change from Baseline at the final measurement was used. For the second analysis (worst value analysis) the series of measurements which has the worst final post-Baseline measurement was used. The series relevant for the analyses was selected from the series for the affected leg or legs only. The selection is 1 out of up to 4 series available per subject. Series without Baseline value and series with at least 1 measurement of more than 150 mmHg were excluded from the selection process due to the suspicion of media sclerosis of the lower limb artery. | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) in case of missing values. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | Posted | Mean | Standard Deviation | mmHg | At 24 weeks after the end of study drug treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minor Amputations at 24 Weeks After the End of Study Drug Treatment | Assessment of amputations was collected per leg affected by a lesion with up to 2 lesions per subject. Amputations were regarded as major if they were performed at the ankle joint level or above. Amputations of toes or part of the foot leaving a stump thereon the subject can walk were regarded as minor. An affected leg is defined as a leg with at least 1 lesion on Study Day -6 to -2 and only amputations of affected legs are considered in the efficacy analysis of amputations. A subject is counted as major/minor amputated, if at least 1 affected leg was major/minor amputated. The number of subjects with minor amputation prior to or at 24 weeks after the end of study drug treatment is presented below. | Of the 838 subjects in the Full Analysis Set (FAS), 613 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | Posted | Number | participants | At 24 weeks after the end of study drug treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment | The number of subjects with revascularization prior to or at 24 weeks after the end of study drug treatment is presented below. | Of the 838 subjects in the Full Analysis Set (FAS), 577 are included in the analysis of this outcome measure. FAS consists of all randomized subjects who received at least one dose of trial medication and who provide valid data to assess at least one of the primary efficacy endpoints. | Posted | Number | participants | At 24 weeks after the end of study drug treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All-cause Mortality During the Course of the Study (up to 196 Days) | Safety Set consists of all randomized subjects who received at least one dose of trial medication. | Posted | Number | participants | During the course of the study (up to 196 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cardiovascular Mortality During the Course of the Study (up to 196 Days) | Safety Set consists of all randomized subjects who received at least one dose of trial medication. | Posted | Number | participants | During the course of the study (up to 196 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cardiovascular Morbidity During the Course of the Study (up to 196 Days) | Cardiovascular morbidity is presented as number of subjects with myocardial infarction and/or stroke during the course of the study. | Safety Set consists of all randomized subjects who received at least one dose of trial medication. | Posted | Number | participants | During the course of the study (up to 196 days) |
|
|
Adverse Events were collected during the course of the study from Study Day 0 up to Study Day 196.
Adverse Events refer to the Safety Set. Safety Set consists of all subjects who have completed the study or terminated prematurely and who have received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alprostadil | Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. Alprostadil: - Active Substance: Prostaglandin E1
| 87 | 416 | 61 | 416 | ||
| EG001 | Placebo | Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. Placebo: - Active Substance: Lactose
| 62 | 423 | 62 | 423 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| CARDIOPULMONARY FAILURE | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| ACUTE RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| NODAL ARRHYTHMIA | Cardiac disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| DUODENAL ULCER | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| MESENTERIC ARTERY EMBOLISM | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| ISCHAEMIC ULCER | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| NECROSIS | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| DEATH | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| IMPAIRED HEALING | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| MULTI-ORGAN FAILURE | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| PAIN | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| WOUND NECROSIS | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| GANGRENE | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| INFECTED SKIN ULCER | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| PURULENT DISCHARGE | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| WOUND INFECTION STAPHYLOCOCCAL | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| ABSCESS LIMB | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| ARTHRITIS BACTERIAL | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| LOBAR PNEUMONIA | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
| |
| LIMB TRAUMATIC AMPUTATION | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| SHUNT THROMBOSIS | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| JAW FRACTURE | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
| |
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| TENOSYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| HYPOPHARYNGEAL CANCER STAGE III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
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| LUNG NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Non-systematic Assessment |
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| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| DIABETIC COMA | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| CEREBROVASCULAR INSUFFICIENCY | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| CONVULSION | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| PSYCHOMOTOR HYPERACTIVITY | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| HYDROTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| PULMONARY ARTERY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| DRY GANGRENE | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| SKIN NECROSIS | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| EXTREMITY NECROSIS | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| NECROSIS ISCHAEMIC | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| CIRCULATORY COLLAPSE | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| ARTERIAL THROMBOSIS LIMB | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| ISCHAEMIA | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| VENOUS THROMBOSIS LIMB | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| THROMBOPHLEBITIS | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| THROMBOSIS | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
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| PERIPHERAL ISCHAEMIA | Vascular disorders | MedDRA (11.0) | Non-systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Superiority or Other |
| Primary goal was to test the following null hypothesis: H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing. This is the statistical analysis of stage 1 and stage 2 combined. | Cochran-Mantel-Haenszel | The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense. | 0.3463 | For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085. | Superiority or Other |
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| OG001 | Placebo | Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. Placebo: - Active Substance: Lactose
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Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks. Placebo: - Active Substance: Lactose
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