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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT00596752
First received: December 21, 2007
Last updated: May 15, 2013
Last verified: May 2013
History of Changes

December 21, 2007
May 15, 2013
March 2004
May 2013   (final data collection date for primary outcome measure)
  • Rate of complete healing of ulcerations after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Frequency of amputations after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of complete healing of ulcerations after 12 weeks [ Time Frame: 12 weeks ]
  • Frequency of amputations after 24 weeks [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00596752 on ClinicalTrials.gov Archive Site
Rate of complete healing of all necroses and ulcerations; Intensity of rest pain; Consumption and type of analgesics; minor amputations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Rate of complete healing of all necroses and ulcerations; Intensity of rest pain; Consumption and type of analgesics; minor amputations [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
Multinational, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Assess the Efficacy and Safety of Prostaglandin E1 in Subjects With Critical Limb Ischemia (Fontaine Stage IV)

The study is to confirmedly show a superior effect of Alprostadil compared to placebo on the rate of complete healing of Ischemic Necroses and Ulcerations.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Peripheral Arterial Occlusive Disease
  • Drug: Alprostadil
    40 µg Alprostadil i.v. b.d. during a Treatment Phase of 4 weeks
  • Other: Placebo
    Placebo i.v. b.d. during a Treatment Phase of 4 weeks
  • Experimental: ALPROSTADIL
    Alprostadil
    Intervention: Drug: Alprostadil
  • Placebo Comparator: PLACEBO
    Placebo treatment
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
840
August 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with macro-angiopathy, proven PAOD Stage IV with 2 ischaemic skin lesions
  • No primary revascularization recommended

Exclusion Criteria:

  • Imminent or foreseeable amputation
  • History of chronic alcohol or drug abuse
  • More than two ischemic ulcerations
  • Acute ischemia and peripheral vascular disorders of inflammatory or immunologic origin
  • Neuropathic or venous ulcers
  • Buerger's disease
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Mexico,   Poland,   Russian Federation,   Ukraine
 
NCT00596752
SP777
No
UCB, Inc. ( UCB Pharma GmbH )
UCB Pharma GmbH
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
May 2013

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