Pain, Post-operativePhase 2NCT02284243

Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery

A Phase 2 study testing Intranasal Dexmedetomidine in people with Pain, Post-operative, run by Baudax Bio at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, 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: 168 participants
Where: 3 sitesUnited States
Study dates: Oct 2014to Jun 2015
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 in DEX-IN/placebo or to any peri- or postoperative medications used in this study.
Have a clinically significant abnormal clinical laboratory test 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

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of Intranasal Dexmedetomidine for Postoperative Analgesia Following 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
Also called DEX-IN
Intranasal PlaceboDrug

Study groups in NCT02284243
Study group	Role	What they receive
DEX-IN 50mcg	Experimental	DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours. Receives: Drug: Intranasal Dexmedetomidine
IN Placebo	Placebo comparator	IN Placebo every 6 hours for 48 hours. Receives: Drug: 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 Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). 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 post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (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

Secondary outcomes (6)

SPID at Various Other Time Points
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). 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 post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (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: Up to 48 Hours
Time to Perceptible and Meaningful Pain Relief
Kaplan-Meier analysis of time to perceptible and meaningful pain relief for 50th percentile of subjects. Time to perceptible pain relief and time to meaningful pain relief were measured using the double-stopwatch method. The first stopwatch was given to each subject with the instructions to stop the watch when they first perceive pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they are first experiencing meaningful pain relief (time to meaningful relief). A shorter time to pain relief is better.
Measured: 6 hours
Number of Subjects With Significant Pain Improvement Following the First Study Dose.
Measured: 6 hours
Use of Rescue Medication (Oral Opioids)
Number of subjects requiring rescue medication (Oral opioids) within 48 hours after first study dose
Measured: 48 hours
Time to First Rescue Medication Use
Kaplan Meier analysis of time to first use of rescue analgesia 50th percentile of subjects. Rescue analgesia (oral oxycodone) was available to subjects with inadequately controlled pain. All doses of rescue analgesia administered were recorded and the time from the first study dose to first rescue analgesia in each subject was evaluated. A longer time to first rescue is better.
Measured: 48 hours
Number of Subjects With Complete Protection From PONV
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Jun 2015

First posted5 Nov 2014 (estimated)
Study startOct 2014
Primary completionJun 2015
Study completionJun 2015

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: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02284243
Sponsor's protocol ID: REC-14-013
Status last verified: Mar 2017
First submitted: 3 Nov 2014
Last updated: 2 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2017. 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 and Safety of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
ClinicalTrials.gov ID: NCT02284243
Acronym / sponsor ID: REC-14-013
Conditions: Pain, Post-operative
Keywords: Bunion, Bunionectomy, Pain, Analgesia, dexmedetomidine, intranasal
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Baudax BioIndustry (pharma, biotech, devices)
Collaborators: Lotus Clinical Research, LLC
Study start: Oct 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 5 Nov 2014 (estimated)
Results: Posted 2 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
DEX-IN 50mcg	Experimental	Drug: Intranasal DexmedetomidineDEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.
IN Placebo	Placebo comparator	Drug: Intranasal PlaceboIN Placebo every 6 hours for 48 hours.

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 in DEX-IN/placebo or to any peri- or postoperative medications used in this study.
Have a clinically significant abnormal clinical laboratory test 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 DexmedetomidineAlso: DEX-IN	Drug	DEX-IN 50mcg
Intranasal Placebo	Drug	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 Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). 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 post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (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.

6 secondary outcomes

SPID at Various Other Time Points
Time frame: Up to 48 Hours
Time to Perceptible and Meaningful Pain Relief
Time frame: 6 hours
Number of Subjects With Significant Pain Improvement Following the First Study Dose.
Time frame: 6 hours
Use of Rescue Medication (Oral Opioids)
Time frame: 48 hours
Time to First Rescue Medication Use
Time frame: 48 hours
Number of Subjects With Complete Protection From PONV
Time frame: 24 hours

Results and safety

Results posted to the registry on 2 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DEX-IN 50mcg	84	80
IN Placebo	84	81

Primary outcome: Summed Pain Intensity Difference Over the First 48 Hours (SPID48).

Time frame: 48 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	DEX-IN 50mcg n = 84	IN Placebo n = 84
Value	-2328.2 (5746.724)	-548.90 (5819.373)

DEX-IN 50mcg vs IN Placebo: p = 0.0180, ANCOVA

Population analysed: mITT population, including all randomized subjects who received at least one study dose

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs were collected through the Day 7 study visit. All SAEs were assessed through the Day 7 visit, but were reported through 30 days of the last study visit if the investigator was made aware of the event.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DEX-IN 50mcg	1 of 84 (1.2%)	51 of 84 (60.7%)	Not reported
IN Placebo	0 of 84 (0%)	36 of 84 (42.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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: finished, as of the sponsor's last update on 2 May 2017. 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 2 May 2017). 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?

On the ClinicalTrials.gov record for NCT02284243.

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 2 May 2017.