Raynaud's PhenomenonPhase 1NCT00700518
Dose Response to Topical Glyceryl Trinitrate in Patients With Raynaud's Phenomenon
A Phase 1 study testing Glyceryl Trinitrate in people with Raynaud's Phenomenon, run by Procris Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Raynaud's Phenomenon
- What is being tested?
- Glyceryl Trinitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Nov 2008
- Phase
- Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female volunteers aged between 18 and 50 inclusive
- Subject has idiopathic RP (patient may have undifferentiated connective tissue disease with positive ANA) diagnosed for more than two (2) years
- If a female, subject must be non-pregnant and non-lactating
- The subject has provided written informed consent prior to admission to this study
Who cannot join
- History of clinically relevant medical illnesses (not considering RP) that in the Investigator's opinion may jeopardize subject's safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, unstable hypertension, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, CNS trauma or active seizure disorders, allergic or immunologically mediated disorders
- History in the past five (5) years of drug or alcohol abuse
- History in the past five (5) years of vascular migraine or other chronic severe headache
- History in the past five (5) years of autonomic neuropathy or postural hypotension
- Unwilling or unable to comply with the restrictions outlined in the protocol
- Current use of smoking cessation treatment, including nicotine patches
Show all 16Show fewer
- History of drug allergies, anaphylaxis or laryngeal oedema, including allergy to GTN, propylene/ethylene glycol or common moisturizing creams
- Use of any nitrate medication or any phosphodiesterase inhibitor within three (3) days prior to or intended use one (1) day following each dosing with study drug
- Currently treated for hypertension
- Currently receiving treatment for prevention and/or treatment of RP
- Use of any investigational medication within 30 days prior to dosing with study medication or scheduled to receive an investigational drug other than during the course of this study
- Open skin lesions or pathological condition (including, but not limited to, infection) in the area where the study medication is to be applied
- Use of topical corticosteroid to the hand or fingers within 10 days of treatment with study drug
- Withdrawal of consent at any time during the study
- Any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study
- Previously enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa-Institute for Clinical and Translational Science
Iowa City, Iowa, 52242
About this study
Official title: A Phase I Trial of the Pharmacodynamic Dose Response to Topical Trinitrate in Patients With Raynaud's Phenomenon
The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.
- Conditions
- Raynaud's Phenomenon
- Being tested
- placebo cream, Glyceryl Trinitrate
- Keywords
- Raynaud's Syndrome, Raynaud's Disease, RP
- Medical subject headings
- Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo creamDrug
placebo cream applied to 2 adjacent fingers of non-dominant hand one time
Glyceryl TrinitrateDrug
0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time
Glyceryl TrinitrateDrug
1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Glyceryl TrinitrateDrug
1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
Glyceryl TrinitrateDrug
2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time
| Study group | Role | What they receive |
|---|---|---|
| 1. | Placebo comparator | placebo cream applied to 2 adjacent fingers on non-dominant hand one time Receives: Drug: placebo cream |
| 2 | Active comparator | 0.6mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand Receives: Drug: Glyceryl Trinitrate |
| 3 | Active comparator | 1.2mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time Receives: Drug: Glyceryl Trinitrate |
| 4 | Active comparator | 1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers on non-dominant hand one time Receives: Drug: Glyceryl Trinitrate |
| 5 | Active comparator | 2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time Receives: Drug: Glyceryl Trinitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate vascular responses to topical Glyceryl Trinitrate versus placebo in patients with Raynaud's using laser Doppler imaging to measure blood flow
Measured: 6 visits no less than 10 hours between visits
Secondary outcomes (2)
Evaluate the dose proportionality of the microvascular response to topical Glyceryl Trinitrate
Measured: 6 visits no less than 10 hours between visits
Compare the systemic versus topical effect of Glyceryl Trinitrate on vascular response.
Measured: 6 visits no less than 10 hours between visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud's PhenomenonStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Procris Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700518
- Sponsor's protocol ID
- P150-005
- Status last verified
- Dec 2008
- First submitted
- 13 Jun 2008
- Last updated
- 30 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of the Pharmacodynamic Dose Response to Topical Trinitrate in Patients With Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT00700518
- Acronym / sponsor ID
- P150-005
- Conditions
- Raynaud's Phenomenon
- Keywords
- Raynaud's Syndrome, Raynaud's Disease, RP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Procris PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 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.
The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1. | Placebo comparator | Drug: placebo creamplacebo cream applied to 2 adjacent fingers on non-dominant hand one time |
| 2 | Active comparator | Drug: Glyceryl Trinitrate0.6mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand |
| 3 | Active comparator | Drug: Glyceryl Trinitrate1.2mg of Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time |
| 4 | Active comparator | Drug: Glyceryl Trinitrate1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers on non-dominant hand one time |
| 5 | Active comparator | Drug: Glyceryl Trinitrate2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female volunteers aged between 18 and 50 inclusive
- Subject has idiopathic RP (patient may have undifferentiated connective tissue disease with positive ANA) diagnosed for more than two (2) years
- If a female, subject must be non-pregnant and non-lactating
- The subject has provided written informed consent prior to admission to this study
Key exclusion criteria (16 listed)
- History of clinically relevant medical illnesses (not considering RP) that in the Investigator's opinion may jeopardize subject's safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, unstable hypertension, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, CNS trauma or active seizure disorders, allergic or immunologically mediated disorders
- History in the past five (5) years of drug or alcohol abuse
- History in the past five (5) years of vascular migraine or other chronic severe headache
- History in the past five (5) years of autonomic neuropathy or postural hypotension
- Unwilling or unable to comply with the restrictions outlined in the protocol
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 |
|---|---|---|
| placebo creamplacebo cream applied to 2 adjacent fingers of non-dominant hand one time | Drug | 1. |
| Glyceryl Trinitrate0.6mg of Glyceryl Trinitrate applied to 2 adjacent fingers on non-dominant hand one time | Drug | 2 |
| Glyceryl Trinitrate1.2mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time | Drug | 3 |
| Glyceryl Trinitrate1.8mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time | Drug | 4 |
| Glyceryl Trinitrate2.4 mg Glyceryl Trinitrate topically to 2 adjacent fingers of non-dominant hand one time | Drug | 5 |
Primary outcome
Investigate vascular responses to topical Glyceryl Trinitrate versus placebo in patients with Raynaud's using laser Doppler imaging to measure blood flow
Time frame: 6 visits no less than 10 hours between visits
2 secondary outcomes
Evaluate the dose proportionality of the microvascular response to topical Glyceryl Trinitrate
Time frame: 6 visits no less than 10 hours between visits
Compare the systemic versus topical effect of Glyceryl Trinitrate on vascular response.
Time frame: 6 visits no less than 10 hours between visits
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 Dec 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 1 study testing Glyceryl Trinitrate in people with Raynaud's Phenomenon, run by Procris Pharmaceuticals 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 16 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 Dec 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. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Investigate vascular responses to topical Glyceryl Trinitrate versus placebo in patients with Raynaud's using laser Doppler imaging to measure blood flow (time frame: 6 visits no less than 10 hours between visits). 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 Dec 2008.