Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients
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|ClinicalTrials.gov Identifier: NCT01393795|
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : February 20, 2013
The investigators hypothesise that pre-application of Qutenza® patches to the skin may reduce pain at the site of Remodulin® SC infusion (sited 1 to 2 weeks later at the site of Qutenza pre-application), in which case it would greatly improve the quality of life of the patients, and enable many more to continue with this treatment. It may also provide new information to support the use of Qutenza® patches for preventing and reducing pain produced by inflammation.
The present study will explore the efficacy of single applications of Qutenza® (capsaicin 8% patch) in reducing site pain caused by continuous SC infusion of Remodulin®, in pulmonary arterial hypertension patients, as assessed by changes in subjective pain rating score and/or pain and sensory testing.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Pain||Drug: Qutenza Drug: Tegaderm||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind, Randomized, Crossover Clinical Study to Assess the Efficacy of Qutenza® for the Reduction of Site Pain Caused by Continuous Subcutaneous Infusion of Remodulin®, in Pulmonary Arterial Hypertension Patients|
|Study Start Date :||August 2011|
|Primary Completion Date :||July 2012|
|Study Completion Date :||July 2012|
|Placebo Comparator: Tegaderm||
No active drug
|Active Comparator: Qutenza||
- Safety Measures [ Time Frame: Approximately 9 months (vital signs, AE's and concomitant medications will be recorded throughout the study) ]
Safety evaluations will be based on the incidence, intensity and type of AEs and clinically significant changes in vital signs (pulse rate, blood pressure, respiration rate, pulse oximetry and temperature), and changes in concomitant medications throughout the study.
Evaluation of safety will also be based on subject's physical examination, signs and symptoms of PAH, routine clinical laboratory tests (hematology, chemistry, coagulation panel, and urinalysis), ECG, and NYHA (WHO) classification at the screening and end of study follow up visits.
- Efficacy measure - change in mean NPRS score [ Time Frame: Approximately 9 months. Average daily NPRS scores from Weeks 1 and 2 of each treatment period will be expressed as percentage changes from the average daily NPRS score at baseline ]The primary efficacy measure will be the change in mean NPRS pain score (reduced by greater than 1.1) at the site of Remodulin® SC infusion, following Qutenza® or transparent adhesive control dressing (Tegaderm film 10cmx12cm) in combination with 0.075% capsaicin cream (Axsain®), during two treatment periods. Efficacy of Qutenza® relative to the control will also be assessed on PGIC, as well as sensory tests and flare area.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393795
|Hammersmith Hospital, Imperial College NHS Trust|
|London, United Kingdom, W120HS|
|Principal Investigator:||Vincenzo Libri, MD||Imperial College London|