NefopamPhase 3NCT05648058
Role of Nefopam in Rituximab Transfusion Reaction
A Phase 3 study testing Nefopam ampule and diphenhydramine ampule in people with Nefopam, run by Ministry Of Health / Nineveh Health Directorate.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nefopam
- What is being tested?
- Nefopam ampule and diphenhydramine ampule
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 20 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 80 years old male and female will be taken rituximab
Who cannot join
- less than 18 years old more than 80 years old diabetic patients
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the detailed description
the two groups will be taken standard therapy (hydrocortisone vial 100 mg and acetaminophen 1000 mg) 30 min before rituximab
- Conditions
- Nefopam
- Being tested
- Nefopam ampule, diphenhydramine ampule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nefopam ampuleDrug
Also called ACUPAN
nefopam ampule 50 mg
diphenhydramine ampuleDrug
Also called Allermine
diphenhydramine ampule 10 mg
| Study group | Role | What they receive |
|---|---|---|
| nefopam | Experimental | administration of intravenous nefopam to prevent Rituximab Transfusion Reaction Receives: Drug: Nefopam ampule |
| diphenhydramine | Active comparator | administration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction Receives: Drug: diphenhydramine ampule |
What is being measured
The primary outcome is the main question the study is designed to answer.
transfusion reaction
fever, riger, rash, chills, pruritus and bronchospasm
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start20 Dec 2022 (estimated)
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NefopamStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry Of Health / Nineveh Health Directorate
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- moataz alani, Study chair, Ministry Of Health / Nineveh Health Directorate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648058
- Sponsor's protocol ID
- nefopam with rituximab
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nefopam in Rituximab Transfusion Reaction
- ClinicalTrials.gov ID
- NCT05648058
- Acronym / sponsor ID
- nefopam with rituximab
- Conditions
- Nefopam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ministry Of Health / Nineveh Health DirectorateOther government
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nefopam | Experimental | Drug: Nefopam ampuleadministration of intravenous nefopam to prevent Rituximab Transfusion Reaction |
| diphenhydramine | Active comparator | Drug: diphenhydramine ampuleadministration of intravenous diphenhydramine to prevent Rituximab Transfusion Reaction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 - 80 years old male and female will be taken rituximab
Key exclusion criteria (1 listed)
- less than 18 years old more than 80 years old diabetic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nefopam ampuleAlso: ACUPANnefopam ampule 50 mg | Drug | nefopam |
| diphenhydramine ampuleAlso: Allerminediphenhydramine ampule 10 mg | Drug | diphenhydramine |
Primary outcome
transfusion reaction
Time frame: 30 min
fever, riger, rash, chills, pruritus and bronchospasm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
moataz alani study chair
Ministry Of Health / Nineveh Health Directorate
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nefopam ampule and diphenhydramine ampule in people with Nefopam, run by Ministry Of Health / Nineveh Health Directorate.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fakhraldin marwan (07817639470, drfakhralin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
transfusion reaction (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.