Systemic SclerosisPhase 2NCT00707187
Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction
A Phase 2 study testing Cialis in people with Systemic Sclerosis, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Cialis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jul 2002
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with diagnosis of scleroderma
- Stable sexual relationship with male partner or be sexually active
- Raynaud phenomenon at least 6 times per week
- Willing to attempt sexual activity 1/month during study period
Who cannot join
- Severe internal organ problems related to scleroderma
- Other gynecologic problems
- Serious depression
- Receiving other experimental and Raynaud treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic Sclerosis
Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma
- Conditions
- Systemic Sclerosis
- Being tested
- Cialis
- Keywords
- systemic sclerosis, scleroderma, raynaud phenomenon
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CialisDrug
35 pills of study medication (20 mg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 35 doses of study medication, IC 351 (20 mg) -- crossover to placebo Receives: Drug: Cialis |
| 2 | Experimental | 35 placebo pills followed with 35 study medication (20 mg) Receives: Drug: Cialis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Raynaud attacks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startJul 2001
- Primary completionJul 2002
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707187
- Sponsor's protocol ID
- 0220013701
- Status last verified
- Jun 2008
- First submitted
- 25 Jun 2008
- Last updated
- 30 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00707187
- Acronym / sponsor ID
- 0220013701
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis, scleroderma, raynaud phenomenon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Study start
- Jul 2001
- Primary completion
- Jul 2002
- Study completion
- Jul 2002
- First posted
- 30 Jun 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.
Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cialis35 doses of study medication, IC 351 (20 mg) -- crossover to placebo |
| 2 | Experimental | Drug: Cialis35 placebo pills followed with 35 study medication (20 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female with diagnosis of scleroderma
- Stable sexual relationship with male partner or be sexually active
- Raynaud phenomenon at least 6 times per week
- Willing to attempt sexual activity 1/month during study period
Key exclusion criteria (4 listed)
- Severe internal organ problems related to scleroderma
- Other gynecologic problems
- Serious depression
- Receiving other experimental and Raynaud treatments
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 |
|---|---|---|
| Cialis35 pills of study medication (20 mg) | Drug | 1, 2 |
Primary outcome
Number of Raynaud attacks
Time frame: 16 weeks
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 30 Jun 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cialis in people with Systemic Sclerosis, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
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 4 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 30 Jun 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Number of Raynaud attacks (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2008.