NCT00740285

Brief Summary

Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The disease is characterized by thickening and fibrosis skin, affecting vessels and many organs such as the esophagus, stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still unknown, but scientists and medical investigators in a wide variety of fields are working hard to make those determinations. It is known that scleroderma involves overproduction of collagen. FLICKMAN et al, in 1973 published an article about the role of lidocaine at prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production. Until now, there is only a case series showing the improvement of thickening skin (75%) and esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a RCT to prove these findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2004

Typical duration for phase_2

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

April 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
Last Updated

August 22, 2008

Status Verified

August 1, 2008

Enrollment Period

2 years

First QC Date

August 19, 2008

Last Update Submit

August 21, 2008

Conditions

Scleroderma

Keywords

sclerodermascleroderma - limited or diffuse typeslidocaineeffectiveness

Outcome Measures

Primary Outcomes (1)

  • Skin thickening evaluated by Skin Score

    before, immediately after the intervention and 6 months later

Secondary Outcomes (5)

  • Safety - evaluated by the adverse effects during the intervention

    immediately after the intervention

  • Quality of Life evaluated by HAQ

    before, immediately after the intervention and 6 months later

  • Pressure at lower esophagus evaluated by esophagus manometry

    before, immediately after the intervention and 6 months later

  • Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy

    before, immediately after the intervention and 6 months later

  • Subjective evaluation by patients

    before, immediately after the intervention and 6 months later

Study Arms (2)

1

EXPERIMENTAL
Drug: Lidocaine 2% without vessel constrictor

2

PLACEBO COMPARATOR
Other: Placebo - physiological solution 0,9%

Interventions

Lidocaine 2% without vessel constrictorDRUG

* first 5 days: 20ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours * next 5 days: 30ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days

1
Placebo - physiological solution 0,9%OTHER

first 5 days: 20ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours next 5 days: 30ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Scleroderma (diffuse or limited) at less than 5 years of the first symptom

You may not qualify if:

  • Overlap with other connective tissue diseases
  • Fibromyalgia
  • Pregnancy
  • Current use of ciclofosfamide ou D-penicillamine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04039-001, Brazil

Location

Related Publications (1)

  • Jimenez SA, Hitraya E, Varga J. Pathogenesis of scleroderma. Collagen. Rheum Dis Clin North Am. 1996 Nov;22(4):647-74. doi: 10.1016/s0889-857x(05)70294-5.

    PMID: 8923589BACKGROUND

MeSH Terms

Conditions

Scleroderma, DiffuseScleroderma, Limited

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Rachel Riera, MD

    Universidade Federal de São Paulo

    PRINCIPAL INVESTIGATOR

  • Virginia FM Trevisani, PhD

    Universidade Federal de São Paulo

    STUDY CHAIR

  • Alexandre WS Silva, PhD

    Universidade Federal de São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 22, 2008

Study Start

April 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2007

Last Updated

August 22, 2008

Record last verified: 2008-08

Locations

BR(1)