Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms (APHYPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03808805
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Phase 3, randomized prospective study, double blind-double placebo, testing oral therapies APREPITANT versus HYDROXYZINE in patients followed for myeloproliferative neoplasms and suffering of persistent aquagenic pruritus.

Condition or disease Intervention/treatment Phase
Myeloproliferative Disorder Aquagenic Pruritus Drug: Aprepitant 80 mg Drug: Hydroxyzine 25mg Drug: Placebo of Hydroxyzine Drug: Placebo of Aprepitant Phase 3

Detailed Description:
Identification of patients with myeloproliferative neoplasms and aquagenic pruritus. Evaluation of the intensity of the aquagenic pruritus. Patients with value >5/10 on the VAS (Visual Analogue Scale ) are proposed to participate to the protocole. Randomization between the two treatments. Duration of the treatment : 14 days. Regular evaluation of efficacity of the drugs (questionnaires). Evaluations will stop 2 months after the last intake. Blood samples will be collected before and after the intakes to study cytokine and neuropeptide levels.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 3, randomized prospective study, double blind-double placebo
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : November 1, 2020


Arm Intervention/treatment
Experimental: studied group
Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days
Drug: Aprepitant 80 mg
oral therapy - daily dose - 14 days

Drug: Placebo of Hydroxyzine
oral therapy - daily dose - 14 days

Active Comparator: comparative group
Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days
Drug: Hydroxyzine 25mg
oral therapy - daily dose - 14 days

Drug: Placebo of Aprepitant
oral therapy - daily dose - 14 days




Primary Outcome Measures :
  1. Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale ) [ Time Frame: at 15 days ]
    number of patients with a pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms)


Secondary Outcome Measures :
  1. Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale ) [ Time Frame: at 60 days ]
    number of patients with a pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms)

  2. Cessation of pruritus [ Time Frame: at 15 days ]
    number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms) )

  3. Cessation of pruritus [ Time Frame: at 60 days ]
    number of patients with a pruritus intensity at 0/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms))

  4. Time observed to decreased the VAS to 3/10 [ Time Frame: 01 to 60 days ]
    number of days to obtain an intensity of pruritus at 3/10 on the VAS (Visual Analogue Scale )

  5. Duration of treatment effectiveness [ Time Frame: 1 to 60 days ]
    number of days the VAS (Visual Analogue Scale ) is below (or equal) 3/10

  6. Adverse event occurring during the association therapeutic [ Time Frame: at 15 days ]
    type of adverse event occuring during the treatment period

  7. Number of prematurely discontinued anti-pruritic treatment [ Time Frame: at 15 days ]
    Total number of prematurely discontinued treatments for all subjects

  8. Complete blood count (normal or abnormal) [ Time Frame: 1 to 60 days ]
    number of patients with hematologic remission : hematocrit <45% with leukocytes <10 giga/l and platelets <400 giga/l

  9. Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire [ Time Frame: at J0 (day of inclusion) ]
    Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire

  10. Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire [ Time Frame: at J0 (day of inclusion) ]
    Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire

  11. Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire [ Time Frame: at 15 days ]
    Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers)questionnaire

  12. Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire [ Time Frame: at 15 days ]
    Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire

  13. Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire [ Time Frame: at 30 days ]
    Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire

  14. Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire [ Time Frame: at 30 days ]
    Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire

  15. Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire [ Time Frame: at 45 days ]
    Evaluation of quality of life by completion of the MPN-SAF(Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire

  16. Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire [ Time Frame: at 45 days ]
    Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire

  17. Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire [ Time Frame: at 60 days ]
    Evaluation of quality of life by completion of the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form calculated as the mean score for 10 items. Questions focus on fatigue, concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, and fevers) questionnaire

  18. Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire [ Time Frame: at 60 days ]
    Evaluation of quality of life by completion of the PASYMPLE (evaluation of pruritus with 7 questions about occurence, timing, intensity and localisation of pruritus) questionnaire

  19. Quantification of the change of plasma concentrations of cytokines and neuropeptides [ Time Frame: at J0 (day of inclusion) ]
    Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)

  20. Quantification of the change of plasma concentrations of cytokines and neuropeptides [ Time Frame: at 15 days ]
    Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)

  21. Quantification of the change of plasma concentrations of cytokines and neuropeptides [ Time Frame: at 30 days ]
    Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)

  22. Quantification of the change of plasma concentrations of cytokines and neuropeptides [ Time Frame: at 60 days ]
    Plasma concentrations of cytokines (ng/L) and neuropeptides (ng/mL)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patients with myeloproliferative neoplasms (polycythemia vera, essential thrombocythaemia or myelofibrosis)
  • and treated with hydroxyurea, pipobroman, anagrelide, α2a pegylated interferon, ruxolitinib or bled for more than 6 months
  • and suffering of persistent aquagenic pruritus
  • and with a pruritus intensity on Analogic Visual Scale >5/10
  • patients who gave their written consent for participation in the study

Exclusion Criteria:

  • patients with a physical or psychological disability to sign the consent form
  • patients with myeloproliferative neoplasms and suffering of aquagenic pruritus but only treated by aspirin
  • patients already included in another therapeutic protocol
  • patients with diffuse dermatological disease where pruritus may be present (psoriasis, atopic dermatitis, prurigo
  • patients already on anti-anxiety and / or anti-depressant treatment
  • patients with absolute contraindications to the use of Aprepitant or Hydroxyzine
  • hypersensitivity to Aprepitant and / or Hydroxyzine or to any of their excipients
  • lactose intolerance
  • pregnant or lactating women

Information from the National Library of Medicine

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): NCT03808805


Contacts
Layout table for location contacts
Contact: Jean-Christophe IANOTTO, MD, PhD 02 98 22 37 86 ext +33 jean-christophe.ianotto@chu-brest.fr

Locations
Layout table for location information
France
CHRU de Brest - Hôpital Morvan Recruiting
Brest, Brest Cedex, France, 29609
Contact: Jean-Christophe IANOTTO, Dr    02 98 22 37 86    jean-christophe.ianotto@chu-brest.fr   
CHU d'Angers Not yet recruiting
Angers, France, 49933
Contact: Françoise BOYER, Dr    02 41 35 54 50    FrBoyer-Perrard@chu-angers.fr   
Centre Hospitalier de Douarnenez Not yet recruiting
Douarnenez, France, 29171
Contact: Anne-Sophie LE BRIS-MICHEL, Dr    02 98 75 15 85    as.lebris@ch-douarnenez.fr   
Centre Hospitalier des Pays de Morlaix Not yet recruiting
Morlaix, France, 29672
Contact: Mohamed MALOU, Pr    02 98 62 60 38    mmalou@ch-morlaix.fr   
Centre Hospitalier de Cornouaille Not yet recruiting
Quimper, France, 29107
Contact: Pascal HUTIN, Dr    02 98 52 61 50 ext +33    p.hutin@ch-cornouaille.fr   
Hôpital Yves Le Foll Not yet recruiting
Saint-Brieuc, France, 22027
Contact: Iuliana MARTINIUC    02 96 01 75 87    iuliana.martiniuc@ch-stbrieuc.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
Layout table for investigator information
Principal Investigator: Jean-Christophe IANOTTO, MD, PhD Hématologie Clinique-Institut de Cancéro-Hématologie

Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03808805     History of Changes
Other Study ID Numbers: ApHyPAP 29BRC18.0036
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pruritus
Myeloproliferative Disorders
Skin Diseases
Skin Manifestations
Signs and Symptoms
Bone Marrow Diseases
Hematologic Diseases
Aprepitant
Fosaprepitant
Hydroxyzine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents