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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
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Occlusive Disease
 Drug: Alprostadil
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Drug Information available for: Alprostadil
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 840
Study Start Date: March 2004
Estimated Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALPROSTADIL
Alprostadil
 Drug: Alprostadil
40 µg Alprostadil i.v. b.d. during a Treatment Phase of 4 weeks
Placebo Comparator: PLACEBO
Placebo treatment
 Other: Placebo
Placebo i.v. b.d. during a Treatment Phase of 4 weeks

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00596752

  Show 78 Study Locations
Sponsors and Collaborators
UCB Pharma GmbH
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier: NCT00596752     History of Changes
Other Study ID Numbers: SP777
Study First Received: December 21, 2007
Last Updated: May 15, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Czech Republic: State Institute for Drug Control
Russia: Ministry of Health of the Russian Federation

Keywords provided by UCB, Inc.:
Alprostadil
Prostavasin

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases
Alprostadil
Platelet Aggregation Inhibitors
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013