NCT00663780

Brief Summary

The objective of the study is to identify variations in subjects genetic makeup that segregate responders from non-responders in respect of response to Juvidex in the clinical trial RN1004-0082

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 6, 2009

Status Verified

January 1, 2009

Enrollment Period

7 months

First QC Date

April 21, 2008

Last Update Submit

January 5, 2009

Conditions

Wound

Keywords

pharmacogenomicspolymorphismswound healing

Outcome Measures

Primary Outcomes (1)

  • To identify polymorphisms that segregate responders from non-responders in respect of response to Juvidex in the clinical trial RN1004-0082

    Single blood sample

Secondary Outcomes (1)

  • Identify polymorphisms associated with differential healing rates and associate data with additional ongoing clinical studies.

    Single Blood Sample

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will analyse samples from subjects participating in clinical study RN1004-0082, a double blind, placebo controlled trial to investigate the efficacy and safety of two concentrations of Juvidex in accelerating the healing of split thickness skin graft donor sites using different dosing regimes.

You may qualify if:

  • Subjects aged 18-85 years who have given written informed consent.
  • Subjects have given written informed consent to participate in the study RN1004-0082.

You may not qualify if:

  • Subjects who are not participating in the study RN1004-0082.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Unit, Renovo Limited

Manchester, M13 9XX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma retained until samples analysed then destroyed

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Jim Bush, MBChB. MRCS

    General Medical Council

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 22, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 6, 2009

Record last verified: 2009-01

Locations

GB(1)