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Clinical Trials/EUCTR2008-000938-49-DE
EUCTR2008-000938-49-DE
Active, not recruiting
Not Applicable

Placebo-controlled Randomized Trial to evaluate the Effect of Elafin on Cytokine Profiles after Major Surgery - Phase II - Elafin

Proteo Biotech AG0 sitesJanuary 27, 2009
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ConditionsEsophagectomy is the surgical removal of all or part of the esophagus. The patients enrolled in the study will undergo this surgery for treatment of esophageal cancer. The condition under investigation is the postoperative inflammatory syndrome (SIRS) after esophagectomy.

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophagectomy is the surgical removal of all or part of the esophagus. The patients enrolled in the study will undergo this surgery for treatment of esophageal cancer. The condition under investigation is the postoperative inflammatory syndrome (SIRS) after esophagectomy.
Sponsor
Proteo Biotech AG
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 27, 2009
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Proteo Biotech AG

Eligibility Criteria

Inclusion Criteria

  • •1\.Subject has carcinoma of the esophagus that will be treated with esophagectomy
  • •2\.Subject is informed and given ample time and opportunity to think about his participation and has given his written informed consent.
  • •3\.Subject is willing and able to comply with all trial requirements.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\.Less than 18 years of age
  • •2\.Child\-bearing potential
  • •3\.Participation in another trial with an investigational product within the last 4 weeks
  • •4\.White blood cell count \< 4,000 cells/mm³
  • •5\.White blood cell count \> 12,000 cells/mm³
  • •6\.Greater than 10% immature neutrophils
  • •7\.Body temperature \> 38°C
  • •8\.Body temperature \< 36°C
  • •9\.Pulse rate \> 90 bpm at eligibility
  • •10\.Serum creatinine \> 2\.0 mg/dL

Outcomes

Primary Outcomes

Not specified

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