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Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers

Primary Purpose

Ulcers

Status
Suspended
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
collagenase (IRUXOL)
collagenase (Kollagenase)
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcers focused on measuring Non-inferiority based on efficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients of both sexes aged over 18 years
  • people with skin ulcers of the lower limbs for at least 3 months

Exclusion Criteria:

  • Lesion with a diameter larger than 12 cm ²
  • injury over 2 years of evolution; injury infected
  • neoplastic lesions in activity
  • poorly controlled diabetes mellitus
  • HAS poorly controlled
  • signs of ischemia in the limb
  • not offset any disease
  • allergic to components of formula
  • urticaria
  • pregnancy
  • breastfeeding
  • emotional disturbance

Sites / Locations

  • Lal Clinica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

patients treated with collagenase (IRUXOL)

patients treated with collagenase (Kollagenase)

Outcomes

Primary Outcome Measures

Primary: Non-inferiority based on efficiency that will be evaluated by the general improvement of the injury; Secondary: tolerability assessed by the incidence of adverse events.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2008
Last Updated
November 1, 2022
Sponsor
Azidus Brasil
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1. Study Identification

Unique Protocol Identification Number
NCT00701974
Brief Title
Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers
Official Title
Study of Non Inferiority of Product Kollagenase ®, Manufactured by Laboratory Cristália When Compared With Iruxol ®, Manufactured by Abbott Laboratory, in the Treatment of Cutaneous Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Sponsor's strategy
Study Start Date
February 2008 (Actual)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are from other causes. Clinical studies show that collagenase is an effective drug and presents high tolerabildade in the treatment of ulcerative burns and injuries of various etiologies. Evidence show statistically significant reduction of inflammation, the formation of granulation tissue, decrease in injuries and reepitelization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcers
Keywords
Non-inferiority based on efficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
patients treated with collagenase (IRUXOL)
Arm Title
2
Arm Type
Experimental
Arm Description
patients treated with collagenase (Kollagenase)
Intervention Type
Biological
Intervention Name(s)
collagenase (IRUXOL)
Intervention Description
patients will be treated with collagenase one time per day.
Intervention Type
Biological
Intervention Name(s)
collagenase (Kollagenase)
Intervention Description
patients will be treated with collagenase one time per day.
Primary Outcome Measure Information:
Title
Primary: Non-inferiority based on efficiency that will be evaluated by the general improvement of the injury; Secondary: tolerability assessed by the incidence of adverse events.
Time Frame
healing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients of both sexes aged over 18 years people with skin ulcers of the lower limbs for at least 3 months Exclusion Criteria: Lesion with a diameter larger than 12 cm ² injury over 2 years of evolution; injury infected neoplastic lesions in activity poorly controlled diabetes mellitus HAS poorly controlled signs of ischemia in the limb not offset any disease allergic to components of formula urticaria pregnancy breastfeeding emotional disturbance
Facility Information:
Facility Name
Lal Clinica
City
Valinhos
State/Province
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers

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