Pulmonary Arterial HypertensionPhase 4NCT01433328
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
A Phase 4 study testing Lidocaine in people with Pulmonary Arterial Hypertension, run by Jewish General Hospital at 1 site in Canada.
Trial summary
Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Apr 2012
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PAH
- Treprostinil treatment for at least 3 months
- Severe infusion site pain
Who cannot join
- Pregnancy/breastfeeding
- Decompensated heart failure
- Chronic liver disease
- Abnormal electrolytes
- Heart block (2/3 degree), sino-atrial block, idioventricular rhythm
- Systolic systemic BP <90mmHg
Show all 9Show fewer
- Bradycardia HR <55
- Adverse reaction to lidocaine or other amide local anesthestic
- Interacting medications (anti-arrhythmics, CYP1A2 inhibitors)
Trial locations and contacts
1 site in 1 country.
About this study
Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Lidocaine, Placebo
- Keywords
- Remodulin, 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.
LidocaineDrug
Lidocaine
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Not described Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Remodulin only Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Questionnaire
Short Form McGill Pain Questionnaire - Change from baseline over one week
Measured: 1 week
Daily Pain Diary
10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week
Measured: 1 week
Secondary outcomes (3)
proNT-BNP
Measured: 1 week
6 minute walk
Measured: 1 week
Lidocaine level
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionApr 2012
Why it stopped: Safety considerations
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
- 4 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, Principal investigator, Chair, Cardiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433328
- Sponsor's protocol ID
- JGH-11-096
- Status last verified
- Jan 2023
- First submitted
- 9 Sep 2011
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
- ClinicalTrials.gov ID
- NCT01433328
- Acronym / sponsor ID
- JGH-11-096
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Remodulin, Treprostinil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety considerations
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Sep 2011 (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.
Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.
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 |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine |
| Placebo | Placebo comparator | Drug: PlaceboRemodulin only |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PAH
- Treprostinil treatment for at least 3 months
- Severe infusion site pain
Key exclusion criteria (9 listed)
- Pregnancy/breastfeeding
- Decompensated heart failure
- Chronic liver disease
- Abnormal electrolytes
- Heart block (2/3 degree), sino-atrial block, idioventricular rhythm
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 |
|---|---|---|
| LidocaineLidocaine | Drug | Lidocaine |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Pain Questionnaire
Time frame: 1 week
Short Form McGill Pain Questionnaire - Change from baseline over one week
Daily Pain Diary
Time frame: 1 week
10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week
3 secondary outcomes
proNT-BNP
Time frame: 1 week
6 minute walk
Time frame: 1 week
Lidocaine level
Time frame: 1 week
Results and safety
The study was stopped early (reason given: Safety considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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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.
David Langleben, MD principal investigator
Chair, Cardiology Department
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 Lidocaine 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 9 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: stopped early, as of the sponsor's last update on 1 Feb 2023. 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. 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 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 stopped early (reason given: Safety considerations). Results are not available in the source record.
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?
Pain Questionnaire (time frame: 1 week). The study lists 2 primary outcomes in all. 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 1 Feb 2023.