NCT05648058

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2022

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

December 20, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

December 4, 2022

Last Update Submit

December 13, 2022

Conditions

Nefopam

Outcome Measures

Primary Outcomes (1)

  • transfusion reaction

    fever, riger, rash, chills, pruritus and bronchospasm

    30 min

Study Arms (2)

nefopam

EXPERIMENTAL

administration of intravenous nefopam to prevent Rituximab Transfusion Reaction

Drug: Nefopam ampule

diphenhydramine

ACTIVE COMPARATOR

administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction

Drug: diphenhydramine ampule

Interventions

Nefopam ampuleDRUG

nefopam ampule 50 mg

Also known as: ACUPAN
nefopam
diphenhydramine ampuleDRUG

diphenhydramine ampule 10 mg

Also known as: Allermine
diphenhydramine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old male and female will be taken rituximab

You may not qualify if:

  • less than 18 years old more than 80 years old diabetic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Nefopam

Intervention Hierarchy (Ancestors)

OxazocinesAzocinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • moataz alani

    Ministry Of Health / Nineveh Health Directorate

    STUDY CHAIR

Central Study Contacts

fakhraldin marwan

CONTACT

07817639470drfakhralin@gmail.com

zainab thanon

CONTACT

07518097301zainabthanon@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2022

First Posted

December 13, 2022

Study Start

December 20, 2022

Primary Completion

October 20, 2023

Study Completion

November 20, 2023

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share