Peripheral Vertigo.Phase 3NCT01827293
Promethazine vs. Lorazepam for Treatment of Vertigo
A Phase 3 study testing Promethazine and Lorazepam in people with Peripheral Vertigo., run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Vertigo.
- What is being tested?
- Promethazine and Lorazepam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteIran
- Study dates
- Apr 2013to Jun 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Background history of positional vertigo
Who cannot join
- Unable to provide informed consent
- Pregnant or possibly pregnant
- Known allergy to study medications
- Use of antiemetic agents in the previous 24 hours
- Evidence of drug-induced vertigo or orthostatic hypotension
- Central pathologies/central origin for vertigo
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Neurology, Emam Hossein Hospital
Tehran, Nezam Abad, 17666-33815
About this study
Official title: Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial
This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.
- Conditions
- Peripheral Vertigo.
- Being tested
- Promethazine, Lorazepam
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PromethazineDrug
LorazepamDrug
| Study group | Role | What they receive |
|---|---|---|
| Promethazine | Active comparator | IV promethazine (25 mg) Receives: Drug: Promethazine; Drug: Lorazepam |
| lorazepam | Active comparator | IV lorazepam (2 mg) Receives: Drug: Promethazine; Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in vertigo intensity.
The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications.
Measured: At 2 hours after intervention.
Secondary outcomes (1)
Efficacy and Safety outcome measures (nausea change-second dose-adverse events).
Secondary outcomes included, mean change in nausea VAS score, need for second dose of study medications, and the rate of drug-related adverse events for the subjects in each study group after intervention.
Measured: At 2-8 hours after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vertigo.Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadi Asadollahi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827293
- Sponsor's protocol ID
- SB-067
- Status last verified
- Jun 2013
- First submitted
- 2 Apr 2013
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promethazine vs. Lorazepam for Treatment of Vertigo in the Emergency Department: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01827293
- Acronym / sponsor ID
- SB-067
- Conditions
- Peripheral Vertigo.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Apr 2013 (estimated)
- 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.
This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promethazine | Active comparator | Drug: Promethazine, Drug: LorazepamIV promethazine (25 mg) |
| lorazepam | Active comparator | Drug: Promethazine, Drug: LorazepamIV lorazepam (2 mg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years or older
- Background history of positional vertigo
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Pregnant or possibly pregnant
- Known allergy to study medications
- Use of antiemetic agents in the previous 24 hours
- Evidence of drug-induced vertigo or orthostatic hypotension
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 |
|---|---|---|
| Promethazine | Drug | Promethazine, lorazepam |
| Lorazepam | Drug | Promethazine, lorazepam |
Primary outcome
Mean change in vertigo intensity.
Time frame: At 2 hours after intervention.
The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications.
1 secondary outcome
Efficacy and Safety outcome measures (nausea change-second dose-adverse events).
Time frame: At 2-8 hours after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
Related trials for Peripheral Vertigo.
Recruiting
Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma
Vestibular Schwannoma
Not yet recruiting
Ai Chi-Based Rehabilitation for Peripheral Unilateral Vestibular Dysfunction
Unilateral Peripheral Vestibular Hypofunction, Vestibular Disorders
Active, not recruitingPhase 1/2
Efficacy of Non-weight Based, Low Dose Dex-Dex Adjuncts in Prolonging Peripheral Nerve Blocks
Postoperative Pain, Nausea and Vomiting, Postoperative
Not yet recruiting
Clinical Trial of Vit D and Calcium for Recurrent BPPV
BPPV, Benign Paroxysmal Positional Vertigo
Recruiting
The SaVe Project-Sarcopenia and Vertigo in Aging Patients With Colorectal Cancer
Colorectal Cancer, Oncologic Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Promethazine and Lorazepam in people with Peripheral Vertigo., run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 6 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 14 Jun 2013. 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 Iran. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in vertigo intensity. (time frame: At 2 hours after intervention.). 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 14 Jun 2013.