NauseaPhase 4NCT00475306
The Montefiore Metoclopramide Study
A Phase 4 study testing metoclopramide 10 mg, Diphenhydramine 25 mg and Metoclopramide 20 mg in people with Nausea and Extrapyramidal Symptoms, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Nausea, Extrapyramidal Symptoms
- What is being tested?
- metoclopramide 10 mg, Diphenhydramine 25 mg and Metoclopramide 20 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary or secondary complaints of nausea/vomiting
- age 21-65
Who cannot join
- pregnancy
- use of anti-histamine or dopamine antagonist as outpatient and/or within last 24 hours of presentation
- previous adverse reaction to study medications
- use of opioid medications prior to study start time within that ED visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide
Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.
Read the detailed description
The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams of metoclopramide is no more effective than placebo. In contrast, investigations focusing on chemotherapy patients and post-operative patients suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting. This emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of metoclopramide by using the visual analog scale.
In addition to evaluation of dose, we will evaluate one of the most common side affects of metoclopramide, akathisia. Akathisia is characterized by a subjective component of restlessness and an objective component in the form of the inability to remain motionless. Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia when dopamine function is impaired in the basal ganglia. In fact, the use of diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a different anti-emetic, prochlorperazine. However, no research has focused on the use of anti-cholinergic medications to reduce metoclopramide induced akathisia. This investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ED patients being treated for nausea/vomiting.
- Conditions
- Nausea, Extrapyramidal Symptoms
- Being tested
- metoclopramide 10 mg, Diphenhydramine 25 mg, Placebo, Metoclopramide 20 mg
- Keywords
- Metoclopramide, Nausea, Akathisia, Emergency department
- Medical subject headings
- Nausea, Psychomotor Agitation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoclopramide 10 mgDrug
an anti-emetic medication
Diphenhydramine 25 mgDrug
used for prophylaxis against akathisia
PlaceboDrug
placebo
Metoclopramide 20 mgDrug
Metoclopramide 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide 20+diphenhydramine | Active comparator | Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes Receives: Drug: Diphenhydramine 25 mg; Drug: Metoclopramide 20 mg |
| Metoclopramide 20+placebo | Active comparator | Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes Receives: Drug: Placebo; Drug: Metoclopramide 20 mg |
| Metoclopramide 10 + placebo | Active comparator | Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes Receives: Drug: metoclopramide 10 mg; Drug: Placebo |
| Metoclopramide 10+diphenhydramine | Active comparator | Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes Receives: Drug: metoclopramide 10 mg; Drug: Diphenhydramine 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea Scale
Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable
Measured: 60 minutes
Secondary outcomes (1)
Number of Participants With Akathisia
The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NauseaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Friedman, Montefiore Medical Center
- Investigators
- Benjamin W Friedman, MD, Principal investigator, Montefiore Medical CenterBrooke Bender, MD, Study director, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475306
- Sponsor's protocol ID
- 07-01-005
- Status last verified
- Nov 2012
- First submitted
- 16 May 2007
- Last updated
- 31 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide
- ClinicalTrials.gov ID
- NCT00475306
- Acronym / sponsor ID
- 07-01-005
- Conditions
- Nausea, Extrapyramidal Symptoms
- Keywords
- Metoclopramide, Nausea, Akathisia, Emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Posted 31 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.
Detailed description
The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams of metoclopramide is no more effective than placebo. In contrast, investigations focusing on chemotherapy patients and post-operative patients suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting. This emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of metoclopramide by using the visual analog scale.
In addition to evaluation of dose, we will evaluate one of the most common side affects of metoclopramide, akathisia. Akathisia is characterized by a subjective component of restlessness and an objective component in the form of the inability to remain motionless. Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia when dopamine function is impaired in the basal ganglia. In fact, the use of diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a different anti-emetic, prochlorperazine. However, no research has focused on the use of anti-cholinergic medications to reduce metoclopramide induced akathisia. This investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ED patients being treated for nausea/vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide 20+diphenhydramine | Active comparator | Drug: Diphenhydramine 25 mg, Drug: Metoclopramide 20 mgMetoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes |
| Metoclopramide 20+placebo | Active comparator | Drug: Placebo, Drug: Metoclopramide 20 mgMetoclopramide 20 mg + placebo, delivered intravenously over 15 minutes |
| Metoclopramide 10 + placebo | Active comparator | Drug: metoclopramide 10 mg, Drug: PlaceboMetoclopramide 10mg + placebo, delivered intravenously over 15 minutes |
| Metoclopramide 10+diphenhydramine | Active comparator | Drug: metoclopramide 10 mg, Drug: Diphenhydramine 25 mgMetoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary or secondary complaints of nausea/vomiting
- age 21-65
Key exclusion criteria (4 listed)
- pregnancy
- use of anti-histamine or dopamine antagonist as outpatient and/or within last 24 hours of presentation
- previous adverse reaction to study medications
- use of opioid medications prior to study start time within that ED visit
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 |
|---|---|---|
| metoclopramide 10 mgan anti-emetic medication | Drug | Metoclopramide 10 + placebo, Metoclopramide 10+diphenhydramine |
| Diphenhydramine 25 mgused for prophylaxis against akathisia | Drug | Metoclopramide 10+diphenhydramine, Metoclopramide 20+diphenhydramine |
| Placeboplacebo | Drug | Metoclopramide 10 + placebo, Metoclopramide 20+placebo |
| Metoclopramide 20 mgMetoclopramide 20 mg | Drug | Metoclopramide 20+diphenhydramine, Metoclopramide 20+placebo |
Primary outcome
Nausea Scale
Time frame: 60 minutes
Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable
1 secondary outcome
Number of Participants With Akathisia
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Benjamin W Friedman, MD principal investigator
Montefiore Medical Center
Brooke Bender, MD study director
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metoclopramide 10 mg, Diphenhydramine 25 mg and Metoclopramide 20 mg in people with Nausea and Extrapyramidal Symptoms, run by Montefiore Medical Center at 1 site in United States.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea Scale (time frame: 60 minutes). 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 31 Dec 2012.