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Role of Nefopam in Rituximab Transfusion Reaction

NCT ID: NCT05648058

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2023-11-20

Brief Summary

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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

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the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab

Conditions

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Nefopam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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nefopam

administration of intravenous nefopam to prevent Rituximab Transfusion Reaction

Group Type EXPERIMENTAL

Nefopam ampule

Intervention Type DRUG

nefopam ampule 50 mg

diphenhydramine

administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction

Group Type ACTIVE_COMPARATOR

diphenhydramine ampule

Intervention Type DRUG

diphenhydramine ampule 10 mg

Interventions

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Nefopam ampule

nefopam ampule 50 mg

Intervention Type DRUG

diphenhydramine ampule

diphenhydramine ampule 10 mg

Intervention Type DRUG

Other Intervention Names

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ACUPAN Allermine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry Of Health / Nineveh Health Directorate

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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moataz alani

Role: STUDY_CHAIR

Ministry Of Health / Nineveh Health Directorate

Central Contacts

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fakhraldin marwan

Role: CONTACT

Phone: 07817639470

Email: [email protected]

zainab thanon

Role: CONTACT

Phone: 07518097301

Email: [email protected]

Other Identifiers

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nefopam with rituximab

Identifier Type: -

Identifier Source: org_study_id