NCT00226889

Brief Summary

Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are capable of inhibiting fibroblast activity may be beneficial if administrered early in the disease course. Thirty adult patients with early SSc will be treated with the endothelin-1 antagonist bosentan for 6 months.Disease progression will be assessed.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 12, 2009

Status Verified

March 1, 2006

Enrollment Period

4 years

First QC Date

September 23, 2005

Last Update Submit

June 11, 2009

Conditions

Systemic Sclerosis (Scleroderma)

Keywords

SclerodermaFibrosisTherapyBosentanEndothelin-1

Outcome Measures

Primary Outcomes (2)

  • Overall clinical progression

  • Degree of deposition of ET-1 in skin

Secondary Outcomes (2)

  • Development of extradermatological manifestations

  • Quality of life

Interventions

bosentanDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Early systemic sclerosis

You may not qualify if:

  • Age \> 70 or \< 18
  • Pregnancy
  • Nursing
  • HIV
  • Hb \< 8.5 g/l
  • Systolic blood pressure \< 85 mmHg
  • Lack of compliance
  • Liver disease
  • Hypersensitivity to bosentan
  • Concurrent us of glibenclamide, ciclosporine A or tacrolimus -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of rheumatology, Rikshospitalet

Oslo, 0026, Norway

Location

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, DiffuseFibrosis

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jan T Gran, Professor

    department of rheumatology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 27, 2005

Study Start

January 1, 2005

Primary Completion

January 1, 2009

Study Completion

June 1, 2009

Last Updated

June 12, 2009

Record last verified: 2006-03

Locations

NO(1)