Post-operative PainPhase 3NCT02310581
Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
A Phase 3 study testing Buprenorphine Sublingual Spray in people with Post-operative Pain, run by INSYS Therapeutics Inc at 3 sites in United States.
Trial summary
This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Buprenorphine Sublingual Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Feb 2015to 19 Mar 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets protocol-specified criteria for qualification and contraception
- Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
- Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for three days, and return for follow up between 7 and 9 days after surgery.
Who cannot join
- History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- the analysis of results
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Austin, Texas, 78728
Study site
Pasadena, Maryland, 21122
Study site
Phoenix, Arizona, 85027
About this study
Official title: A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period.
Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.
- Conditions
- Post-operative Pain
- Being tested
- Buprenorphine Sublingual Spray, Placebo
- Keywords
- Bunionectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine Sublingual SprayDrug
Buprenorphine sublingual spray delivered via single 100 μL spray
PlaceboDrug
Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine 0.5 mg TID | Experimental | Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. Receives: Drug: Buprenorphine Sublingual Spray; Drug: Placebo |
| Buprenorphine 1.0 mg BID | Experimental | Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. Receives: Drug: Buprenorphine Sublingual Spray; Drug: Placebo |
| Buprenorphine 1.0 mg TID | Experimental | Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. Receives: Drug: Buprenorphine Sublingual Spray; Drug: Placebo |
| Placebo | Placebo comparator | Participants received placebo-matching buprenorphine sublingual spray four times daily for two days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Measured: Baseline and 0 to 48 hours after Time 0
Secondary outcomes (6)
NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline.
Measured: Baseline and 4, 8, 24 and 48 hours after Time 0
NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.
Measured: 4, 8, 24 and 48 hours after Time 0
NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 4 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-4 range is -40 to 40. The NRS SPID-4 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Measured: Baseline and 0 to 4 hours after Time 0
NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 8 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-8 range is -80 to 80. The NRS SPID-8 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Measured: Baseline and 0 to 8 hours after Time 0
NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 24 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-24 range is -240 to 240. The NRS SPID-24 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Measured: Baseline and 0 to 24 hours after Time 0
Percentage of Participants Who Used Rescue Medication for Pain
The percentage of participants who needed to take an alternate medication for pain relief during the study.
Measured: From Time 0 (first dose of study drug) up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start24 Feb 2015
- Primary completion19 Mar 2015
- Study completion19 Mar 2015
Why it stopped: Business decision
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 Post-operative PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni DeCastro, Study director, INSYS Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310581
- Sponsor's protocol ID
- INS-14-026
- Status last verified
- Jun 2017
- First submitted
- 1 Dec 2014
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
- ClinicalTrials.gov ID
- NCT02310581
- Acronym / sponsor ID
- INS-14-026
- Conditions
- Post-operative Pain
- Keywords
- Bunionectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 40 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2015 (actual)
- Primary completion
- 19 Mar 2015 (actual)
- Study completion
- 19 Mar 2015 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Posted 9 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 3, multicenter, randomized, double-blind, multiple-dose, parallel-group, placebo-controlled study to evaluate the safety and efficacy of up to 3 dosing regimens of Buprenorphine Sublingual (under the tongue) Spray and/or matching placebo in participants with moderate to severe postoperative pain after bunionectomy. The study will comprise 4 periods: the Screening Period, the Surgical Period, the Treatment Period, and the Follow-up Period.
Participants will be admitted to the study site on the morning of the scheduled surgery, will remain at the study site until postoperative Day 3 (a total of 3 nights at the study site), and will return for the Follow-up Visit 5 to 9 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine 0.5 mg TID | Experimental | Drug: Buprenorphine Sublingual Spray, Drug: PlaceboParticipants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. |
| Buprenorphine 1.0 mg BID | Experimental | Drug: Buprenorphine Sublingual Spray, Drug: PlaceboParticipants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. |
| Buprenorphine 1.0 mg TID | Experimental | Drug: Buprenorphine Sublingual Spray, Drug: PlaceboParticipants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo-matching buprenorphine sublingual spray four times daily for two days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets protocol-specified criteria for qualification and contraception
- Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
- Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for three days, and return for follow up between 7 and 9 days after surgery.
Key exclusion criteria (5 listed)
- History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
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 |
|---|---|---|
| Buprenorphine Sublingual SprayBuprenorphine sublingual spray delivered via single 100 μL spray | Drug | Buprenorphine 0.5 mg TID, Buprenorphine 1.0 mg BID, Buprenorphine 1.0 mg TID |
| PlaceboPlacebo-matching buprenorphine sublingual spray delivered via single 100 μL spray | Drug | Buprenorphine 0.5 mg TID, Buprenorphine 1.0 mg BID, Buprenorphine 1.0 mg TID, Placebo |
Primary outcome
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
Time frame: Baseline and 0 to 48 hours after Time 0
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
6 secondary outcomes
NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
Time frame: Baseline and 4, 8, 24 and 48 hours after Time 0
NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
Time frame: 4, 8, 24 and 48 hours after Time 0
NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)
Time frame: Baseline and 0 to 4 hours after Time 0
NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)
Time frame: Baseline and 0 to 8 hours after Time 0
NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)
Time frame: Baseline and 0 to 24 hours after Time 0
Percentage of Participants Who Used Rescue Medication for Pain
Time frame: From Time 0 (first dose of study drug) up to Day 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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.
Giovanni DeCastro study director
INSYS Therapeutics Inc
3 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 Buprenorphine Sublingual Spray in people with Post-operative Pain, run by INSYS Therapeutics Inc 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 3 inclusion and 5 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 9 Aug 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 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 9 Aug 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?
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48) (time frame: Baseline and 0 to 48 hours after Time 0). 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 9 Aug 2017.