SedationPhase 3NCT01438931
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery or Medical Procedure Without Intubation
A Phase 3 study testing DA-9501 in people with Sedation, run by Hospira, now a wholly owned subsidiary of Pfizer at 18 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure 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?
- DA-9501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 18 sitesJapan
- Study dates
- Jul 2011to Mar 2012
- 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 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 at the preoperative diagnosis.
- New York Heart Association (NYHA) classification is I to III (Only patients who need classification of cardiac performance.)
- Patient who requires sedation during the following elective surgery or procedure which require ≥30mins (expected time) without intubation under monitored sedation care.
- Orthopedic, Otorhinologic, Oral surgeries, AV fistulas, Plastic, Excision of lesion, Breast biopsy, Catheter ablation, Vascular stents and AV shunt
- Patient who requires local or regional 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 neurosurgical or cerebrovascular catheter procedures or interventions.
- Patient who require general anesthesia, epidural anesthesia or spinal anesthesia for surgery or procedure.
- Patient who receives treatment by alpha-2 agonists or alpha-2 antagonists within seven days of scheduled surgery or procedure.
Show all 13Show fewer
- Patient in whom opioids, DA-9501 or other alpha-2 agonists, or drugs which may be used in the study are contraindicated.
- Patient diagnosed unstable angina or acute myocardiac infarction within 6 weeks from the date of consent.
- Patient whose heart rate less than 50 bpm, systolic blood pressure less than 90 mm Hg by the physical examination prior to the study drug administration.
- Patient has third degree heart block, unless the patient has a pacemaker.
- 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, patient has any symptom or factor, which might increase risk to the patient by conducting the study or preclude obtaining satisfactory study data.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Japan18 sites
Hyogo Prefectural Amagasaki Hospital
Amagasaki, Hyōgo
Asahikawa Medical University Hospital
Asahikawa, Hokkaido
Saitama Medical University International Medical Center
Hidaka, Saitama
Kansai Medical University Hirakata Hospital
Hirakata, Osaka
Shimane University Hospital
Izumo, Shimane
Kagoshima University Medical and Dental Hospital
Kagoshima, Kagoshima-ken
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Kyoto
University of Miyazaki Hospital
Miyazaki, Miyazaki
Okayama University Hospital
Okayama, Okayama-ken
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Osaka, Osaka
Osaka Police Hospital
Osaka, Osaka
Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka
Osaka University Dental Hospital
Suita, Osaka
Keio University Hospital
Tokyo
Tokyo Women's Medical University Hospital
Tokyo
Yuaikai Toyomijo Chuo Hospital
Toyomijo, Okinawa
Tsukuba University Hospital
Tsukuba, Ibaraki
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 or Medical Procedure Without Intubation Under Monitored Sedation Care
The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure 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 or medical procedure under monitored sedation care.
- Conditions
- Sedation
- Being tested
- DA-9501, placebo
- Keywords
- Dexmedetomidine, Sedation, Non-intubation, local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-9501Drug
Dexmedetomidine hydrochloride variable dose
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Loading infusion of Placebo over 10 minutes followed by maintenance infusion of Placebo Receives: Drug: placebo |
| DA-9501 0.5 mcg/kg group | Active comparator | Loading infusion of Dexmedetomidine 3.0 mcg/kg/hr over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.2-0.7 mcg/kg/hr Receives: Drug: DA-9501 |
| DA-9501 1.0 mcg/kg group | Active comparator | Loading infusion of Dexmedetomidine 6.0 mcg/kg/hr over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.2-0.7 mcg/kg/hr Receives: Drug: DA-9501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence 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 during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Secondary outcomes (9)
Administration frequency and dosage of propofol required to achieve and maintain OAA/S score ≤4 during the study drug administration
If the OAA/S score is 5, 0.2 mg/kg of propofol as a sedative is administered intravenously by slow "IV push" and the administration is to be repeated until the target level of sedation (OAA/S score ≤4) is achieved.
Measured: After the start of study drug (20 ± 2 minutes), if the OAA/S score is 5.
Time to first rescue administration of propofol
Measured: ≥15 minutes after the start of study drug infusion.
Incidence 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.
Administration frequency and dosage of fentanyl required 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.
Percentage of time spent OAA/S Score ≤4 during the study drug infusion
Measured: Pre-dose, every 5 ± 2 minutes during 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 during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Time to attain an Aldrete score ≥9 following discontinuation of the study drug infusion
Measured: Every 15 ± 2 minutes until the total score value becomes ≥9.
Visual Analogue Scale (VAS) score evaluation by Investigator or sub-investigator (ease of maintaining sedation level, hemodynamic stability, respiratory stability, subject's cooperativeness)
Measured: Within 24 hours after completion of the study drug administration
Score evaluation of satisfaction and anxiety of the subject
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 startJul 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies 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
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maruishi Pharmaceutical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438931
- Sponsor's protocol ID
- DEX-301
- Status last verified
- Jul 2015
- First submitted
- 21 Sep 2011
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Inagaki Y, Morita K, Ozaki M, Matsumoto K, Okayama A, Oya N, Hiraoka T, Takeda J. The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan. Yonago Acta Med. 2022 Jan 21;65(1):26-43. doi: 10.33160/yam.2022.02.005. eCollection 2022 Feb.
PubMed 35221758
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. 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 or Medical Procedure Without Intubation Under Monitored Sedation Care
- ClinicalTrials.gov ID
- NCT01438931
- Acronym / sponsor ID
- DEX-301
- Conditions
- Sedation
- Keywords
- Dexmedetomidine, Sedation, Non-intubation, local anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Maruishi Pharmaceutical
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Sep 2011 (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.
The purpose of this study is to evaluate the efficacy and the safety of DA-9501 (Dexmedetomidine) in sedation during the surgery or medical procedure 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 or medical procedure 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: placeboLoading infusion of Placebo over 10 minutes followed by maintenance infusion of Placebo |
| DA-9501 0.5 mcg/kg group | Active comparator | Drug: DA-9501Loading infusion of Dexmedetomidine 3.0 mcg/kg/hr over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.2-0.7 mcg/kg/hr |
| DA-9501 1.0 mcg/kg group | Active comparator | Drug: DA-9501Loading infusion of Dexmedetomidine 6.0 mcg/kg/hr over 10 minutes followed by maintenance infusion of Dexmedetomidine 0.2-0.7 mcg/kg/hr |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 at the preoperative diagnosis.
- New York Heart Association (NYHA) classification is I to III (Only patients who need classification of cardiac performance.)
- Patient who requires sedation during the following elective surgery or procedure which require ≥30mins (expected time) without intubation under monitored sedation care.
Key exclusion criteria (13 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 neurosurgical or cerebrovascular catheter procedures or interventions.
- Patient who require general anesthesia, epidural anesthesia or spinal anesthesia for 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 |
|---|---|---|
| DA-9501Dexmedetomidine hydrochloride variable dose | Drug | DA-9501 0.5 mcg/kg group, DA-9501 1.0 mcg/kg group |
| placebo | Drug | Placebo group |
Primary outcome
Incidence 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 during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
9 secondary outcomes
Administration frequency and dosage of propofol required to achieve and maintain OAA/S score ≤4 during the study drug administration
Time frame: After the start of study drug (20 ± 2 minutes), if the OAA/S score is 5.
Time to first rescue administration of propofol
Time frame: ≥15 minutes after the start of study drug infusion.
Incidence 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.
Administration frequency and dosage of fentanyl required 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.
Percentage of time spent OAA/S Score ≤4 during the study drug infusion
Time frame: Pre-dose, every 5 ± 2 minutes during 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 during study drug infusion and every 15 ± 2 minutes until 1 hour after study drug infusion. Before additional administration of sedative.
Time to attain an Aldrete score ≥9 following discontinuation of the study drug infusion
Time frame: Every 15 ± 2 minutes until the total score value becomes ≥9.
Visual Analogue Scale (VAS) score evaluation by Investigator or sub-investigator (ease of maintaining sedation level, hemodynamic stability, respiratory stability, subject's cooperativeness)
Time frame: Within 24 hours after completion of the study drug administration
Score evaluation of satisfaction and anxiety of the subject
Time frame: Within 24 hours after completion of the study drug administration (as much as possible)
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 24 Jul 2015.
- Derived from this study: PubMed 35221758Inagaki Y, Morita K, Ozaki M, Matsumoto K, Okayama A, Oya N, Hiraoka T, Takeda J. The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan. Yonago Acta Med. 2022 Jan 21;65(1):26-43. doi: 10.33160/yam.2022.02.005. eCollection 2022 Feb.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 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 DA-9501 in people with Sedation, run by Hospira, now a wholly owned subsidiary of Pfizer at 18 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 7 inclusion and 13 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 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
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?
Incidence 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 during 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 NCT01438931, 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 24 Jul 2015.