SedationPhase 3NCT01438957
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation
A Phase 3 study testing Dexmedetomidine hydrochloride in people with Sedation, run by Pfizer at 12 sites in Japan.
Trial summary
The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sedation
- What is being tested?
- Dexmedetomidine hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 12 sitesJapan
- Study dates
- 3 Jun 2011to 18 Nov 2011
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed and dated the Informed Consent after the study had been fully explained.
- Patient is male or female, at least 20 years of age when the Informed Consent is obtained.
- American Society for Anesthesiologists (ASA) I to III Class.
- Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.
- Patient undergoing a surgery requiring epidural or spinal anesthesia
Who cannot join
- Patient who underwent general anesthesia within 7 days, or who received other study drugs within 30 days from the date of consent.
- Patient with <92% SpO2, at the physical examination prior to the study drug administration, or ventilatory failure which requires intubation or Laryngeal Mask.
- Patient with central nervous system pathology which may lead to increased intracranial pressure, uncontrolled seizures, psychiatric disorder which may be confused with the response to sedation treatment.
- Patient who require general anesthesia.
- Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
- Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.
Show all 12Show fewer
- Patient diagnosed with unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
- Patient whose heart rate is <60 bpm, systolic blood pressure is <90 mmHg by the physical examination prior to the study drug administration.
- Patient has third degree heart block, unless the patient has a pacemaker or transverse pacing wires are in place.
- Patient who has experienced an increase in alanine transaminase (ALT) and / or aspartate aminotransferase (AST) more than double the upper normal limit within 2 months of the date of consent, or who has a history of liver insufficiency.
- Pregnant or lactating woman.
- In the Investigator's or subinvestigator's opinion, the patient has any symptom or condition which might increase risk to the patient by conducting the study or preclude obtaining satisfactory study data
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Asahikawa Medical University Hospital
Asahikawa, Hokkaido
Shimane University Hospital
Izumo, Shimane
Japanese Red Cross Kyoto Daini Hospital
Kyoto
Shinshul University Hospital
Matsumoto, Nagano
University of Miyazaki Hospital
Miyazaki
Nagoya University Hospital
Nagoya, Aichi-ken
Kochi Medical School Hospital
Nangoku, Kochi
Okayama University Hospital
Okayama
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Osaka
Sapporo Medical University Hospital
Sapporo, Hokkaido
Nippon Medical University Hospital
Tokyo
Tottori University Hospital
Yonago, Tottori
About this study
Official title: Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation Under Monitored Sedation Care
The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care.
Read the detailed description
Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery with spinal or epidural anesthesia under monitored sedation care
- Conditions
- Sedation
- Being tested
- Dexmedetomidine hydrochloride, Placebo
- Keywords
- Dexmedetomidine, Sedation, Non-intubation, epidural anesthesia, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine hydrochlorideDrug
Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Dexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose Receives: Drug: Placebo |
| Dexmedetomidine 0.067 mcg/kg | Experimental | Dexmedetomidine 0.4 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose Receives: Drug: Dexmedetomidine hydrochloride |
| Dexmedetomidine 0.25 mcg/kg | Experimental | Dexmedetomidine 1.5 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose Receives: Drug: Dexmedetomidine hydrochloride |
| Dexmedetomidine 0.5 mcg/kg | Experimental | Dexmedetomidine 3 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose Receives: Drug: Dexmedetomidine hydrochloride |
| Dexmedetomidine 1.0 mcg/kg | Experimental | Dexmedetomidine 6 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose Receives: Drug: Dexmedetomidine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration.
Measured: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Secondary outcomes (19)
Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
Measured: 15 minutes after the start of study drug, if the OAA/S score is 5.
Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
Measured: 15 minutes after the start of study drug, if the OAA/S score is 5.
Time to First Rescue Administration of Propofol
Measured: During the study drug infusion period (≥15 minutes [Approximate])
Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration
Measured: After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.
Number of Fentanyl Dosing Required During the Study Drug Administration.
Measured: During the study drug administration
Dosage of Fentanyl Dosing Required During the Study Drug Administration.
Measured: During the study drug administration
Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion
Measured: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion
Measured: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion
Measured: Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8.
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level)
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State)
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State)
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation)
VAS score ranges from 0 to 10, with 0 being the better/preferred outcome. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration
Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure")
Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery")
Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("If You May Undergo a Similar Surgery, the Same Anesthesia Procedure Will be Requested for the Next Time")
Rating: 1 is the better/preferred value for scores from 1 to 4. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery")
Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery")
Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery")
Rating: 1 is the better/preferred value for scores from 1 to 5. Low values indicated more ease of maintenance of sedation level.
Measured: Within 24 hours after completion of the study drug administration (as much as possible)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study start3 Jun 2011
- Primary completion18 Nov 2011
- Study completion18 Nov 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maruishi Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438957
- Sponsor's protocol ID
- DEX-303
- Status last verified
- Mar 2021
- First submitted
- 21 Sep 2011
- Last updated
- 22 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Publications
Inagaki Y, Yamakage M, Sakamoto A, Okayama A, Oya N, Hiraoka T, Morita K. The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study. Yonago Acta Med. 2022 Jan 4;65(1):14-25. doi: 10.33160/yam.2022.02.002. eCollection 2022 Feb.
PubMed 35221757
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Placebo-controlled Double Blind Comparative Study to Investigate the Efficacy and Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation Under Monitored Sedation Care
- ClinicalTrials.gov ID
- NCT01438957
- Acronym / sponsor ID
- DEX-303
- Conditions
- Sedation
- Keywords
- Dexmedetomidine, Sedation, Non-intubation, epidural anesthesia, spinal anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Maruishi Pharmaceutical
- Study start
- 3 Jun 2011 (actual)
- Primary completion
- 18 Nov 2011 (actual)
- Study completion
- 18 Nov 2011 (actual)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Posted 22 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored sedation care.
Detailed description
Phase III, randomized, placebo controlled, double blind, parallel comparative study (Therapeutic confirmatory trial), to evaluate the efficacy and the safety of Dexmedetomidine in non-intubated patients who require sedation during surgery with spinal or epidural anesthesia under monitored sedation care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDexmedetomidine 0 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0 mcg/kg/hr Maintenance dose |
| Dexmedetomidine 0.067 mcg/kg | Experimental | Drug: Dexmedetomidine hydrochlorideDexmedetomidine 0.4 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose |
| Dexmedetomidine 0.25 mcg/kg | Experimental | Drug: Dexmedetomidine hydrochlorideDexmedetomidine 1.5 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose |
| Dexmedetomidine 0.5 mcg/kg | Experimental | Drug: Dexmedetomidine hydrochlorideDexmedetomidine 3 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose |
| Dexmedetomidine 1.0 mcg/kg | Experimental | Drug: Dexmedetomidine hydrochlorideDexmedetomidine 6 mcg/kg/hr 10 min Initial dose + Dexmedetomidine 0.2 - 0.7 mcg/kg/hr Maintenance dose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has signed and dated the Informed Consent after the study had been fully explained.
- Patient is male or female, at least 20 years of age when the Informed Consent is obtained.
- American Society for Anesthesiologists (ASA) I to III Class.
- Patient who requires sedation during the elective surgery which requires ≥30mins (expected time) without intubation under monitored sedation care.
- Patient undergoing a surgery requiring epidural or spinal anesthesia
Key exclusion criteria (12 listed)
- Patient who underwent general anesthesia within 7 days, or who received other study drugs within 30 days from the date of consent.
- Patient with <92% SpO2, at the physical examination prior to the study drug administration, or ventilatory failure which requires intubation or Laryngeal Mask.
- Patient with central nervous system pathology which may lead to increased intracranial pressure, uncontrolled seizures, psychiatric disorder which may be confused with the response to sedation treatment.
- Patient who require general anesthesia.
- Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
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 |
|---|---|---|
| Dexmedetomidine hydrochlorideDexmedetomidine 0.2 to 0.7 mcg/kg/hr | Drug | Dexmedetomidine 0.067 mcg/kg, Dexmedetomidine 0.25 mcg/kg, Dexmedetomidine 0.5 mcg/kg, Dexmedetomidine 1.0 mcg/kg |
| Placebo | Drug | Placebo |
Primary outcome
Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration.
Time frame: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
19 secondary outcomes
Number of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
Time frame: 15 minutes after the start of study drug, if the OAA/S score is 5.
Dosage of Propofol Dosing Required to Achieve and Maintain OAA/S Score ≤4 During the Study Drug Administration
Time frame: 15 minutes after the start of study drug, if the OAA/S score is 5.
Time to First Rescue Administration of Propofol
Time frame: During the study drug infusion period (≥15 minutes [Approximate])
Percentage of Patients Who Did Not Require Rescue Administration of Fentanyl During the Study Drug Administration
Time frame: After the surgery start, the administration of fentanyl is permissible as required to treat pain. In case of repeated dose, the dosing interval should be ≥15 minutes.
Number of Fentanyl Dosing Required During the Study Drug Administration.
Time frame: During the study drug administration
Dosage of Fentanyl Dosing Required During the Study Drug Administration.
Time frame: During the study drug administration
Percentage of Time Spent OAA/S Score ≤4 During the Study Drug Infusion
Time frame: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Percentage of Time Spent OAA/S Score 3 to 4 During the Study Drug Infusion
Time frame: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Time to Attain the Point Where Patient is Recovered Assessed by Aldrete Score Following Discontinuation of the Study Drug Infusion
Time frame: Every 15 ± 2 minutes until the score of each item becomes ≥1 and the total value becomes ≥8.
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Easiness of Maintenance of Sedation Level)
Time frame: Within 24 hours after completion of the study drug administration
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Hemodynamic State)
Time frame: Within 24 hours after completion of the study drug administration
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Stability of Respiratory State)
Time frame: Within 24 hours after completion of the study drug administration
Visual Analogue Scale (VAS) Score Evaluation by Investigator or Sub-investigator (Subject's Cooperation)
Time frame: Within 24 hours after completion of the study drug administration
Score Evaluation of Satisfaction and Anxiety of the Subject ("I Was Satisfied With This Anesthesia Procedure")
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("I Did Not Feel Pain During the Surgery")
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("If You May Undergo a Similar Surgery, the Same Anesthesia Procedure Will be Requested for the Next Time")
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level Before Surgery")
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level During Surgery")
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Score Evaluation of Satisfaction and Anxiety of the Subject ("Assess the Anxiety Level After Surgery")
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35221757Inagaki Y, Yamakage M, Sakamoto A, Okayama A, Oya N, Hiraoka T, Morita K. The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study. Yonago Acta Med. 2022 Jan 4;65(1):14-25. doi: 10.33160/yam.2022.02.002. eCollection 2022 Feb.
Related trials for Sedation
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruitingObservational study
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
Anesthesia, Anxiety
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.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine hydrochloride in people with Sedation, run by Pfizer at 12 sites in Japan.
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 5 inclusion and 12 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 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2021). 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?
Percentage of Patients Who Did Not Require Rescue Administration of Propofol to Achieve and Maintain Observer's Assessment of Alertness/Sedation (OAA/S) Score ≤4 During the Study Drug Administration. (time frame: Pre-dose, every 5 ± 2 minutes after start of study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01438957, which also lists 1 linked publication.
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 22 Mar 2021.