Pulmonary Arterial HypertensionPhase 4NCT01615627
Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain
A Phase 4 study testing HypotonicTreprostinil Solution and Eutonic Treprostinil Solution in people with Pulmonary Arterial Hypertension, run by Jewish General Hospital at 1 site in Canada.
Trial summary
The investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- HypotonicTreprostinil Solution and Eutonic Treprostinil Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2012to 28 Feb 2019
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PAH by standard criteria
- Treatment with subcutaneous remodulin infusion for at least 3 months, with stable dose for 1 month
- Pain at infusion site (defined as > 8 on McGill Pain Questionnaire)
Who cannot join
- Known pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- HypotonicTreprostinil Solution, Eutonic Treprostinil Solution
- Keywords
- Subcutaneous Treprostinil
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypotonicTreprostinil SolutionDrug
Also called Hypotonic Remodulin Solution
Hypotonic Treprostinil Solution
Eutonic Treprostinil SolutionDrug
Also called Eutonic Remodulin Solution
Eutonic Treprostinil Solution
| Study group | Role | What they receive |
|---|---|---|
| Hypotonic Treprostinil Solution | Experimental | Hypotonic Treprostinil Solution Receives: Drug: HypotonicTreprostinil Solution |
| Eutonic Treprostinil Solution | Active comparator | Eutonic Treprostinil Solution Receives: Drug: Eutonic Treprostinil Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Pain Diary
Measured: 2 weeks
Secondary outcomes (4)
McGill Pain Questionnaire
Measured: 2 weeks
CAMPHOR quality of life questionnaire
Measured: 2 weeks
6 minute walk distance
Measured: 2 weeks
NT-proBNP level
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study start1 Jul 2012
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr David Langleben, Jewish General Hospital
- Investigators
- David Langleben, MD, Study chair, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615627
- Sponsor's protocol ID
- JGH-12-058
- Status last verified
- Feb 2020
- First submitted
- 6 Jun 2012
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain
- ClinicalTrials.gov ID
- NCT01615627
- Acronym / sponsor ID
- JGH-12-058
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Subcutaneous Treprostinil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 8 Jun 2012 (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 investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotonic Treprostinil Solution | Experimental | Drug: HypotonicTreprostinil SolutionHypotonic Treprostinil Solution |
| Eutonic Treprostinil Solution | Active comparator | Drug: Eutonic Treprostinil SolutionEutonic Treprostinil Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PAH by standard criteria
- Treatment with subcutaneous remodulin infusion for at least 3 months, with stable dose for 1 month
- Pain at infusion site (defined as > 8 on McGill Pain Questionnaire)
Key exclusion criteria (1 listed)
- Known pregnancy or breastfeeding
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 |
|---|---|---|
| HypotonicTreprostinil SolutionAlso: Hypotonic Remodulin SolutionHypotonic Treprostinil Solution | Drug | Hypotonic Treprostinil Solution |
| Eutonic Treprostinil SolutionAlso: Eutonic Remodulin SolutionEutonic Treprostinil Solution | Drug | Eutonic Treprostinil Solution |
Primary outcome
Daily Pain Diary
Time frame: 2 weeks
4 secondary outcomes
McGill Pain Questionnaire
Time frame: 2 weeks
CAMPHOR quality of life questionnaire
Time frame: 2 weeks
6 minute walk distance
Time frame: 2 weeks
NT-proBNP level
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
David Langleben, MD study chair
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HypotonicTreprostinil Solution and Eutonic Treprostinil Solution in people with Pulmonary Arterial Hypertension, run by Jewish General Hospital at 1 site in Canada.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 3 Mar 2020. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Daily Pain Diary (time frame: 2 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 3 Mar 2020.