Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 October 2023
• Main ID: NCT01393795
• Date of registration: 22/06/2011
• Prospective Registration: Yes
• Primary sponsor: Imperial College London
• Public title: Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients
• Scientific 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
• Date of first enrolment: August 2011
• Target sample size: 11
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01393795
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Vincenzo Libri, MD
• Affiliation: Imperial College London

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years or older with symptomatic PAH

- Willing to provide written informed consent to participate in the study.

- With documented diagnosis of PAH, either idiopathic, familial or associated with
connective tissue disease, congenital heart disease or the use of anorexogenic drugs.

- Documented haemodynamic diagnosis of PAH by right heart catheterization - performed at
any time prior to screening, showing: mean pulmonary arterial pressure >25 mm Hg,
pulmonary capillary wedge pressure =/< 15 mmHg and pulmonary vascular resistance >240
dynes/sec/cm

- Receiving stable doses of Remodulin® SC, continuously infused at a dose of at least
2.5 ng/kg/min for at least 8 weeks prior to enrolment. Additional medications that are
approved for treatment of PAH (either bosentan or sildenafil) and other supplementary
treatments such as oral anticoagulants, diuretics, digitalis, calcium channel blockers
or oxygen supplementation are permitted.

- History of pain at the site of Remodulin® SC infusion for at least 8 weeks prior to
enrolment and as assessed on the 11 point pain intensity numerical pain rating scale
(NPRS) from 0 to 10, where 0 represents "No pain" and 10 represents "Maximum pain
imaginable". Patients with a history of pain intensity equal or greater than 3 NPRS
points (as determined by the NPRS trial diary completed during the screening period)
are eligible to participate.

- Modified New York Heart Association (NYHA) (WHO) classification II-IV that has been
stable for at least 8 weeks prior to enrolment.

- A female subject is eligible to participate if she is of:

- Non-childbearing potential defined as pre-menopausal females with a documented
tubal ligation or hysterectomy; or postmenopausal defined as 12 months of
spontaneous amenorrhea [in questionable cases a blood sample with simultaneous
follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol <40 pg/ml (<140
pmol/L) is confirmatory].

- Child-bearing potential and agrees to use one of the contraception methods listed
in the protocol.

Exclusion Criteria:

- Patient's participating in another clinical trial or who have done so within 30 days
before screening.

- Patients with PAH in NYHA/WHO functional class I at screening.

- Known to be positive for human immunodeficiency virus (HIV).

- Patients with any additional medical condition or illness that, in the opinion of the
Investigator would interfere with study compliance and/or impair the patient's ability
to participate or complete the study.

- Patients with a history of substance abuse (e.g. alcohol or drug abuse) within the
previous 6 months before enrolment.

- Patients with a history of severe allergies or multiple drug allergies and/or reported
hypersensitivity to capsaicin.

- Patients with no history of pain at the site of Remodulin® SC infusion or average pain
intensity at screening less than 3 points on the numerical pain rating scale (NPRS).

- Life expectancy less than 12 months.

- Unable to provide informed consent.

- Female patients who are lactating or pregnant (positive pre-randomisation serum
pregnancy test) or plan to become pregnant during the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Pain

Intervention(s)

Drug: Tegaderm

Drug: Qutenza

Primary Outcome(s)

Safety Measures [Time Frame: Approximately 9 months (vital signs, AE's and concomitant medications will be recorded throughout the study)]

Secondary Outcome(s)

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]

Secondary ID(s)

CRO1824

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United Therapeutics