Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV (ESPECIAL)

This study has been completed.
Sponsor:
Collaborator:
Aptiv Solutions
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT00596752
First received: December 21, 2007
Last updated: October 17, 2014
Last verified: July 2014
Results First Received: May 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Peripheral Arterial Occlusive Disease
Interventions: Drug: Alprostadil
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

  • Pharmaceutical Form: solution for infusion
  • Concentration: 40 μg b.d.
  • Route of Administration: intravenous infusion
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

  • Pharmaceutical Form: solution for infusion
  • Concentration: 40 μg b.d.
  • Route of Administration: intravenous infusion

Participant Flow:   Overall Study
    Alprostadil     Placebo  
STARTED     415     425  
Randomized and Treated     415     424  
COMPLETED     289     282  
NOT COMPLETED     126     143  
Other Reason                 44                 49  
Adverse Event                 34                 34  
Lost to Follow-up                 22                 38  
Withdrawal by Subject                 12                 9  
Unsatisfactory Compliance                 9                 6  
Lack of Efficacy                 4                 7  
Protocol Violation                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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

  • Pharmaceutical Form: solution for infusion
  • Concentration: 40 μg b.d.
  • Route of Administration: intravenous infusion
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

  • Pharmaceutical Form: solution for infusion
  • Concentration: 40 μg b.d.
  • Route of Administration: intravenous infusion
Total Total of all reporting groups

Baseline Measures
    Alprostadil     Placebo     Total  
Number of Participants  
[units: participants]
  416     423     839  
Age  
[units: years]
Mean ± Standard Deviation
  66.8  ± 8.5     66.4  ± 9.3     66.6  ± 8.9  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     153     170     323  
>=65 years     263     253     516  
Gender  
[units: participants]
     
Female     123     117     240  
Male     293     306     599  
Study-Specific Measure  
[units: kilogram¬†(kg)]
Mean ± Standard Deviation
  75.4  ± 11.9     76.6  ± 12.6     76.0  ± 12.2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment   [ Time Frame: At 12 weeks after the end of study drug treatment ]

2.  Primary:   Occurrence of Major Amputations at 24 Weeks After the End of Study Drug Treatment   [ Time Frame: At 24 weeks after the end of study drug treatment ]

3.  Secondary:   Complete Healing of Ischemic Necroses and Ulcerations at 24 Weeks After the End of Study Drug Treatment   [ Time Frame: At 24 weeks after the end of study drug treatment ]

4.  Secondary:   Intensity of Rest Pain Induced by Ischemic Lesions at 24 Weeks After the End of Study Drug Treatment   [ Time Frame: At 24 weeks after the end of study drug treatment ]

5.  Secondary:   Increase/Decrease in Ulcer Area of ≥ 50 % at 24 Weeks After the End of Study Drug Treatment   [ Time Frame: At 24 weeks after the end of study drug treatment ]

6.  Secondary:   Consumption and Type of Analgesic Medication During the Course of the Study (up to 196 Days)   [ Time Frame: During the course of the study (up to 196 days) ]

7.  Secondary:   Systolic Pressure at Ankle Level at 24 Weeks After the End of Study Drug Treatment   [ Time Frame: At 24 weeks after the end of study drug treatment ]

8.  Secondary:   Minor Amputations at 24 Weeks After the End of Study Drug Treatment   [ Time Frame: At 24 weeks after the end of study drug treatment ]

9.  Secondary:   Revascularization Procedures at 24 Weeks After the End of Study Drug Treatment   [ Time Frame: At 24 weeks after the end of study drug treatment ]

10.  Secondary:   All-cause Mortality During the Course of the Study (up to 196 Days)   [ Time Frame: During the course of the study (up to 196 days) ]

11.  Secondary:   Cardiovascular Mortality During the Course of the Study (up to 196 Days)   [ Time Frame: During the course of the study (up to 196 days) ]

12.  Secondary:   Cardiovascular Morbidity During the Course of the Study (up to 196 Days)   [ Time Frame: During the course of the study (up to 196 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1 877 822 9493 (UCB)


No publications provided


Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT00596752     History of Changes
Other Study ID Numbers: SP0777, 2005-001970-29
Study First Received: December 21, 2007
Results First Received: May 5, 2014
Last Updated: October 17, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Mexico: Federal Commission for Protection Against Health Risks
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health