SclerodermaPhase 2/3NCT00740285
Effectiveness and Safety of Lidocaine for Scleroderma
A Phase 2/3 study testing Lidocaine 2% without vessel constrictor in people with Scleroderma, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Scleroderma
- What is being tested?
- Lidocaine 2% without vessel constrictor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2004to Apr 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Scleroderma (diffuse or limited) at less than 5 years of the first symptom
Who cannot join
- Overlap with other connective tissue diseases
- Fibromyalgia
- Pregnancy
- Current use of ciclofosfamide ou D-penicillamine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial
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.
- Conditions
- Scleroderma
- Being tested
- Lidocaine 2% without vessel constrictor, Placebo - physiological solution 0,9%
- Keywords
- scleroderma, scleroderma - limited or diffuse types, lidocaine, effectiveness
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Limited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Lidocaine 2% without vessel constrictor |
| 2 | Placebo comparator | Not described Receives: Other: Placebo - physiological solution 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin thickening evaluated by Skin Score
Measured: before, immediately after the intervention and 6 months later
Secondary outcomes (5)
Safety - evaluated by the adverse effects during the intervention
Measured: immediately after the intervention
Quality of Life evaluated by HAQ
Measured: before, immediately after the intervention and 6 months later
Pressure at lower esophagus evaluated by esophagus manometry
Measured: before, immediately after the intervention and 6 months later
Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy
Measured: before, immediately after the intervention and 6 months later
Subjective evaluation by patients
Measured: before, immediately after the intervention and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startApr 2004
- Primary completionApr 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Rachel Riera, MD, Principal investigator, Universidade Federal de São PauloVirginia FM Trevisani, PhD, Study chair, Universidade Federal de São PauloAlexandre WS Silva, PhD, Study director, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740285
- Sponsor's protocol ID
- 390/00
- Status last verified
- Aug 2008
- First submitted
- 19 Aug 2008
- Last updated
- 22 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8923589
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT00740285
- Acronym / sponsor ID
- 390/00
- Conditions
- Scleroderma
- Keywords
- scleroderma, scleroderma - limited or diffuse types, lidocaine, effectiveness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lidocaine 2% without vessel constrictor |
| 2 | Placebo comparator | Other: Placebo - physiological solution 0,9% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Scleroderma (diffuse or limited) at less than 5 years of the first symptom
Key exclusion criteria (4 listed)
- Overlap with other connective tissue diseases
- Fibromyalgia
- Pregnancy
- Current use of ciclofosfamide ou D-penicillamine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 2% without vessel constrictor* 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 | Drug | 1 |
| Placebo - physiological solution 0,9%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 | Other | 2 |
Primary outcome
Skin thickening evaluated by Skin Score
Time frame: before, immediately after the intervention and 6 months later
5 secondary outcomes
Safety - evaluated by the adverse effects during the intervention
Time frame: immediately after the intervention
Quality of Life evaluated by HAQ
Time frame: before, immediately after the intervention and 6 months later
Pressure at lower esophagus evaluated by esophagus manometry
Time frame: before, immediately after the intervention and 6 months later
Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy
Time frame: before, immediately after the intervention and 6 months later
Subjective evaluation by patients
Time frame: before, immediately after the intervention and 6 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2008.
- Background: PubMed 8923589Jimenez 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.
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Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Riera, MD principal investigator
Universidade Federal de São Paulo
Virginia FM Trevisani, PhD study chair
Universidade Federal de São Paulo
Alexandre WS Silva, PhD study director
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lidocaine 2% without vessel constrictor in people with Scleroderma, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin thickening evaluated by Skin Score (time frame: before, immediately after the intervention and 6 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2008.