Pain, Post-operativePhase 2NCT02169336
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
A Phase 2 study testing Intranasal Dexmedetomidine in people with Pain, Post-operative, run by Baudax Bio at 3 sites in United States.
Trial summary
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Post-operative
- What is being tested?
- Intranasal Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2014to Oct 2014
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily provide written informed consent.
- Male or female between 18 and 70 years of age, inclusive.
- Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair
- Be American Society of Anesthesiology (ASA) physical class 1 or 2.
- Female subject are eligible only if all the following apply:
- Not pregnant;
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- Not lactating;
- Not planning to become pregnant during the study;
- Be surgically sterile; or at least two year post menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive.
- Male subjects must be surgically sterile or commit to the use of a reliable method of birth control
- Have a body mass index ≤35 kg/m2
- Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
Who cannot join
- Have a known allergy to dexmedetomidine or any excipient DEX-IN/placebo or to any peri- or postoperative medications used in this study.
- Have a clinically significant abnormal clinical laboratory tests value.
- Have history of or positive test results for HIV, or hepatitis B or C.
- Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
- Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
- Have another painful physical condition that may confound the assessments of post operative pain.
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- Have a history of syncope or other syncopal attacks.
- Have evidence of a clinically significant 12 lead ECG abnormality.
- Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse..
- Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
- Have a history or evidence of orthostatic hypotension.
- Have a resting heart rate of <50 beats per minutes or systolic blood pressure <100mmHg.
- Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months.
- Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigator's opinion may exert significant analgesic properties or act synergistically with DEX-IN.
- Unable to discontinue medications, that have not been at a stable dose for at least 14 days prior to the scheduled bunionectomy procedure, within 5 half lives of the specific prior medication (or, if half life is not known, within 48 hours) before dosing.
- Have utilized any intranasal medications within the preceding 10 days.
- Have signs or a history of significant rhinitis or rhinorrhea (constant or chronic), nasal polyps, mucosal lesions of the nostril, postnasal drip of any etiology (constant or chronic), nasal ulcers, septal perforation or deviation, any nasal surgery, anosmia, nasal piercings, or frequent nosebleeds or other nasal pathology, that is sufficient to interfere with IN drug delivery.
- Have had an upper respiratory tract infection within 14 days of screening.
- Have utilized corticosteroids, either systemically, inhalational either intranasally or oral, or by intra-articular injection, within 14 days prior to the study.
- Have received any investigational product within 30 days before dosing with study medication.
- Have previously received DEX-IN in clinical trials, or had bunionectomy in the last 3 months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Trovare Clinical Research, Inc.
Bakersfield, California
Lotus Clinical Research, LLC
Pasadena, California
Endeavor Clinical Trials, P.A.
San Antonio, Texas
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy, Safety, and Pharmacokinetics of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.
- Conditions
- Pain, Post-operative
- Being tested
- Intranasal Dexmedetomidine, Intranasal Placebo
- Keywords
- Bunion, Bunionectomy, Pain, Analgesia, dexmedetomidine, intranasal
- Medical subject headings
- Pain, Postoperative, Bunion, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal DexmedetomidineDrug
Intranasal PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| DEX-IN 35mcg | Experimental | DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days. Receives: Drug: Intranasal Dexmedetomidine |
| DEX-IN 50mcg | Experimental | DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days. Receives: Drug: Intranasal Dexmedetomidine |
| IN Placebo | Placebo comparator | IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days. Receives: Other: Intranasal Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Difference Over the First 48 Hours (SPID48).
Pain intensity was recorded using a Numeric Rating Scale (Range 0-10) where 0 equates to no pain, and 10 equates to the worst pain imaginable. Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours. Pain intensity differences from baseline at each time point were calculated and a time weighted SPID was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionOct 2014
Why it stopped: Lack of observed efficacy
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 Pain, Post-operativeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baudax Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lotus Clinical Research, LLC
- Responsible party
- Sponsor
- Investigators
- Neil Singla, MD, Principal investigator, Lotus Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169336
- Sponsor's protocol ID
- REC-13-012
- Status last verified
- Nov 2015
- First submitted
- 17 Jun 2014
- Last updated
- 10 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy, Safety, and Pharmacokinetics of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
- ClinicalTrials.gov ID
- NCT02169336
- Acronym / sponsor ID
- REC-13-012
- Conditions
- Pain, Post-operative
- Keywords
- Bunion, Bunionectomy, Pain, Analgesia, dexmedetomidine, intranasal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of observed efficacy
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Baudax BioIndustry (pharma, biotech, devices)
- Collaborators
- Lotus Clinical Research, LLC
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 10 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.
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 |
|---|---|---|
| DEX-IN 35mcg | Experimental | Drug: Intranasal DexmedetomidineDEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days. |
| DEX-IN 50mcg | Experimental | Drug: Intranasal DexmedetomidineDEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days. |
| IN Placebo | Placebo comparator | Other: Intranasal PlaceboIN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily provide written informed consent.
- Male or female between 18 and 70 years of age, inclusive.
- Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair
- Be American Society of Anesthesiology (ASA) physical class 1 or 2.
- Female subject are eligible only if all the following apply:
Key exclusion criteria (21 listed)
- Have a known allergy to dexmedetomidine or any excipient DEX-IN/placebo or to any peri- or postoperative medications used in this study.
- Have a clinically significant abnormal clinical laboratory tests value.
- Have history of or positive test results for HIV, or hepatitis B or C.
- Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
- Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
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 |
|---|---|---|
| Intranasal Dexmedetomidine | Drug | DEX-IN 35mcg, DEX-IN 50mcg |
| Intranasal Placebo | Other | IN Placebo |
Primary outcome
Summed Pain Intensity Difference Over the First 48 Hours (SPID48).
Time frame: 48 hours
Pain intensity was recorded using a Numeric Rating Scale (Range 0-10) where 0 equates to no pain, and 10 equates to the worst pain imaginable. Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours. Pain intensity differences from baseline at each time point were calculated and a time weighted SPID was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- 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.
Neil Singla, MD principal investigator
Lotus Clinical Research, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal Dexmedetomidine in people with Pain, Post-operative, run by Baudax Bio at 3 sites 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 12 inclusion and 21 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: stopped early, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Dec 2015). 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?
Summed Pain Intensity Difference Over the First 48 Hours (SPID48). (time frame: 48 hours). 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 10 Dec 2015.