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Role of Nefopam in Rituximab Transfusion Reaction

Primary Purpose

Nefopam

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nefopam ampule
diphenhydramine ampule
Sponsored by
Ministry Of Health / Nineveh Health Directorate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nefopam

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 - 80 years old male and female will be taken rituximab Exclusion Criteria: less than 18 years old more than 80 years old diabetic patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    nefopam

    diphenhydramine

    Arm Description

    administration of intravenous nefopam to prevent Rituximab Transfusion Reaction

    administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction

    Outcomes

    Primary Outcome Measures

    transfusion reaction
    fever, riger, rash, chills, pruritus and bronchospasm

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2022
    Last Updated
    December 13, 2022
    Sponsor
    Ministry Of Health / Nineveh Health Directorate
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05648058
    Brief Title
    Role of Nefopam in Rituximab Transfusion Reaction
    Official Title
    Role of Nefopam in Rituximab Transfusion Reaction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 20, 2022 (Anticipated)
    Primary Completion Date
    October 20, 2023 (Anticipated)
    Study Completion Date
    November 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ministry Of Health / Nineveh Health Directorate

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    the patients will be taken nefopam ampule 50 mg before rituximab in the first group while the second group will be taken diphenhydramine ampule 10 mg before rituximab in the second group
    Detailed Description
    the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nefopam

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    nefopam
    Arm Type
    Experimental
    Arm Description
    administration of intravenous nefopam to prevent Rituximab Transfusion Reaction
    Arm Title
    diphenhydramine
    Arm Type
    Active Comparator
    Arm Description
    administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction
    Intervention Type
    Drug
    Intervention Name(s)
    Nefopam ampule
    Other Intervention Name(s)
    ACUPAN
    Intervention Description
    nefopam ampule 50 mg
    Intervention Type
    Drug
    Intervention Name(s)
    diphenhydramine ampule
    Other Intervention Name(s)
    Allermine
    Intervention Description
    diphenhydramine ampule 10 mg
    Primary Outcome Measure Information:
    Title
    transfusion reaction
    Description
    fever, riger, rash, chills, pruritus and bronchospasm
    Time Frame
    30 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 - 80 years old male and female will be taken rituximab Exclusion Criteria: less than 18 years old more than 80 years old diabetic patients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    fakhraldin marwan
    Phone
    07817639470
    Email
    drfakhralin@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    zainab thanon
    Phone
    07518097301
    Email
    zainabthanon@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    moataz alani
    Organizational Affiliation
    Ministry Of Health / Nineveh Health Directorate
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Role of Nefopam in Rituximab Transfusion Reaction

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