Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients

NCT01393795 | Completed Phase 2 DMC

• 1 other identifier: CRO1824
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Hypertension; Pain

Keywords

Pulmonary Hypertension; Pain

Outcome Measures

Primary Outcomes (1)

• Safety Measures

  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.

  Approximately 9 months (vital signs, AE's and concomitant medications will be recorded throughout the study)

Secondary Outcomes (1)

• Efficacy measure - change in mean NPRS score

  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

Study Arms (2)

Tegaderm

PLACEBO COMPARATOR

Drug: Tegaderm

Qutenza

ACTIVE COMPARATOR

Drug: Qutenza

Interventions

Qutenza DRUG

8% patch

Qutenza

Tegaderm DRUG

No active drug

Tegaderm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• United Therapeutics: collaborator

Study Sites (1)

Hammersmith Hospital, Imperial College NHS Trust

London, W120HS, United Kingdom

Location

Related Publications (1)

• Libri V, Gibbs JS, Pinato DJ, Iddamalgoda T, Khengar RH, Gin-Sing W, Huson L, Anand P. Capsaicin 8% patch for treprostinil subcutaneous infusion site pain in pulmonary hypertension patients. Br J Anaesth. 2014 Feb;112(2):337-47. doi: 10.1093/bja/aet308. Epub 2013 Sep 22.

  PMID: 24062200 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Vincenzo Libri, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: July 13, 2011
• Study Start: August 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

GB (1)