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Clinical Characteristics of Aquagenic Pruritus in Patients With Myeloproliferative Neoplasms (PASYMPLE)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688490
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

Description of the characteristics of aquagenic pruritus expressed by patients suffering from myeloproliferative neoplasms.

Prospective work based on the distribution of a dedicated questionnaire.


Condition or disease
Myeloproliferative Disorder

Detailed Description:

Patients with myeloproliferative neoplasms identified and followed in our Institution (Brest University Hospital). Patients could be followed for polycythemia vera or essential thrombocythemia or myelofibrosis.

Distribution of the questionnaire to each patients with myeloproliferative neoplasms (treated or not) suffering from aquagenic pruritus.

Analyse of each characteristic of the aquagenic pruritus by a statistician and publication at the end.

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aquagenic Pruritus Among Patients With Myeloproliferative Syndromes (in English) Prurit Aquagénique Dans Les SYndromes MyéloProLifEratifs (in French)
Actual Study Start Date : July 17, 2013
Actual Primary Completion Date : November 4, 2013
Actual Study Completion Date : November 4, 2013





Primary Outcome Measures :
  1. Intensity of the pruritus [ Time Frame: 15 days ]
    Analogic Visual Scale, from 0 to 10, Worse if >6


Secondary Outcome Measures :
  1. Duration of the pruritus [ Time Frame: 15 days ]
    Timing expresses in minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed for myeloproliferative neoplasms in our Institution (Brest University Hospital)
Criteria

Inclusion Criteria:

  • patients followed with myeloproliferative neoplasms
  • suffering from aquagenic pruritus

Exclusion Criteria:

  • Unable to fulfil the questionnaire
  • No written informed consent

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): NCT03688490


Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: IANOTTO Jean-Christophe, MD, PhD Hématologie Clinique-Institut de Cancéro-Hématologie
Publications of Results:
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03688490    
Other Study ID Numbers: PASYMPLE
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
aquagenic pruritus
Additional relevant MeSH terms:
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Myeloproliferative Disorders
Pruritus
Skin Diseases
Skin Manifestations
Bone Marrow Diseases
Hematologic Diseases