A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertensio

• Conditions: Pulmonary arterial hypertension (PAH) is a rare life-threatening disease characterised by high blood pressure in the arteries to the lungs, rapidly evolving in a clinical syndrome of dyspnoea and fatigue and eventually leading to right ventricular failure and death.; MedDRA version: 13.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2011-001312-59-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-15
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Male or female patients 18 years or older with symptomatic PAH. 2.Willing to provide written informed consent to participate in the study. 3.With documented diagnosis of PAH, either idiopathic, familial or associated with connective tissue disease, congenital heart disease or the use of anorexogenic drugs. 4.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/cm5. 5.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. 6.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. [The use of systemic analgesics to relieve pain at the site of Remodulin® SC infusion, including salicylates, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, as well as topical analgesic-containing gels or creams (such as capsaicin 0.025% and 0.075% cream) and local anesthetics such as lidocaine are also permitted providing they remain unchanged for the entire duration of the study (i.e. from screening to the end of study follow up visit).] 7.Modified New York Heart Association (NYHA) (WHO) classification II-IV that has been stable for at least 8 weeks prior to enrolment. 8.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 following contraception methods: oAbstinence oContraceptive Methods with a Failure Rate of < 1%: - Oral contraceptive, either combined or progestogen alone; - Injectable progestogen; - Implants of levonorgestrel; - Estrogenic vaginal ring; - Percutaneous contraceptive patches; - - Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label; - Male partner(s) sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study; - Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus vaginal spermicidal agent (foam/gel/film/cream/suppository).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patient’s participating in another clinical trial or who have done so within 30 days before screening. 2.Patients with PAH in NYHA/WHO functional class I at screening. 3.Known to be positive for human immunodeficiency virus (HIV). 4.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. Concurrent diseases or conditions that may interfere with study participation or safety include bleeding disorders, arrhythmias, organ transplant, organ failure, current neoplasm, poorly controlled diabetes mellitus, poorly controlled hypertension, clinically significant haematological or biochemical abnormality, and serious neurological disorders. 5.Patients with a history of substance abuse (e.g. alcohol or drug abuse) within the previous 6 months before enrolment. 6.Patients with a history of severe allergies or multiple drug allergies and/or reported hypersensitivity to capsaicin. 7.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). 8.Life expectancy less than 12 months. 9.Unable to provide informed consent. 10.Female patients who are lactating or pregnant (positive pre-randomisation serum pregnancy test) or plan to become pregnant during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified