Role of Nefopam in Rituximab Transfusion Reaction | NCT05648058

Studies
Role of Nefopam in Rituximab Transfusion Reaction

NCT05648058

Sponsor

Ministry Of Health / Nineveh Health Directorate

Status

Unknown status

Last Update Posted

Dec 15, 2022Actual

Enrollment

100Estimated

Phase

Phase 3

Conditions

Nefopam

Interventions

Nefopam ampule
diphenhydramine ampule

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2022Estimated

Primary Completion Date

Oct 20, 2023Estimated

Completion Date

Nov 20, 2023Estimated

First Submitted Date

Dec 4, 2022

First Submission Date that Met QC Criteria

Dec 4, 2022

First Posted Date

Dec 13, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2022

Last Update Posted Date

Dec 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nefopam ampule	Drug	nefopam ampule 50 mg	nefopam	ACUPAN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
transfusion reaction	fever, riger, rash, chills, pruritus and bronchospasm	30 min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
fakhraldin marwan	Contact	07817639470		drfakhralin@gmail.com
zainab thanon	Contact	07518097301		zainabthanon@gmail.com

Overall Officials

Name	Affiliation	Role
moataz alani	Ministry Of Health / Nineveh Health Directorate	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009340	Nefopam

Ancestor Terms

ID	Term
D010079	Oxazocines
D001392	Azocines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided