Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-05-31

Brief Summary

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In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.

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Detailed Description

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Conditions

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Digital Ulcers Systemic Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bosentan

The patients received bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks and then 125 mg b.i.d. for 20 weeks

Group Type EXPERIMENTAL

Bosentan 62.5 mg

Intervention Type DRUG

Oral tablets containing 62.5 mg of bosentan

Bosentan 125 mg

Intervention Type DRUG

Oral tablets containing 125 mg of bosentan

Placebo

The patients received the matching placebo for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets

Interventions

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Bosentan 62.5 mg

Oral tablets containing 62.5 mg of bosentan

Intervention Type DRUG

Bosentan 125 mg

Oral tablets containing 125 mg of bosentan

Intervention Type DRUG

Placebo

Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets

Intervention Type DRUG

Other Intervention Names

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Ro 47-0203 Ro 47-0203

Eligibility Criteria

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Inclusion Criteria

* Systemic Sclerosis (SSc), diffuse or limited.
* SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.

Exclusion Criteria

* Digital ulcers due to conditions other than SSc.
* Severe pulmonary arterial hypertension (PAH) (Who class III and IV).
* Malabsorption or any severe organ failure (e.g., lung, kidney, liver) or any life-threatening condition.
* Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, or prostacyclin analogs) during the past 3 months prior to randomization.
* Treatment with inhaled or oral prostanoids one month prior to randomization.
* Previous treatment with bosentan.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No