PainPhase 2NCT01871285

Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film

A Phase 2 study testing Buprenorphine, Oxycodone and Morphine sulfate in people with Pain, run by BioDelivery Sciences International 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 aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose without inducing opioid withdrawal or… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Pain
What is being tested?: Buprenorphine, Oxycodone and Morphine sulfate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 3 sitesUnited States
Study dates: Jun 2013to Jul 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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Written informed consent obtained prior to any study-related procedure being performed
Male or non-lactating female subjects 18 to 60 years of age at time of consent
Female subjects who are non-pregnant on the basis of screening serum pregnancy test and who are practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method) or have been post-menopausal, biologically sterile, or surgically sterile (ie, hysterectomy, bilateral oophorectomy, or tubal ligation) for more than 1 year
Male subjects who are practicing abstinence, surgically sterile or are using a medically acceptable form of contraception
Subjects with a ≥6 months history of chronic pain (including peripheral neuropathic pain) requiring ATC opioid therapy with ≥80 mg but ≤220 mg MSE per day for at least 28 days
Receiving one of the following opioids ATC for ≥28 days: (i) Morphine Sulfate; (ii) Oxycodone hydrochloride

Show all 9Show fewer

Displays signs and symptoms of withdrawal (ie, COWS score ≥5) within 5 minutes following naloxone challenge
Able to understand the study procedures, complete the assessment scales, and communicate meaningfully with study personnel
Stable health, as determined by the Principal Investigator, on the basis of medical history, physical examination, and screening laboratory results

Who cannot join

Inability to meet study participation requirements, including two 2-night stays with pharmacokinetic sampling
A history or current evidence of clinically significant pulmonary (eg, asthma, chronic obstructive pulmonary disease, cor pulmonale or severe bronchial asthma ), gastrointestinal, hepatic, renal, hematologic, immunologic, endocrine, neurologic, oncologic or psychiatric disorder or any other condition, including evidence of abnormalities on physical examination, abnormal vital signs, electrocardiogram (ECG), or clinical laboratory values which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
Supine systolic blood pressure >180 mm Hg or <90 mm Hg or diastolic blood pressure > 105 mm Hg or <50 mm Hg at screening (may be repeated once)
COWS score greater than 4 prior to the screening naloxone challenge
Aspartate aminotransferase or alanine aminotransferase >3 times the upper limits of normal or serum creatinine >1.9 mg/dL at Screening, or any laboratory abnormality which, in the opinion of the Investigator, would contraindicate study participation
Use of monoamine oxidase inhibitors within 14 days of screening or during the study

Show all 25Show fewer

Use of any medication, nutraceutical or herbal product with cytochrome P450 3A4 inhibition or induction properties within the past 30 days
Donation of 450 mL or more of blood within 30 days prior to screening or a hemoglobin value <11.0 g/dL at screening
Documented history of alcohol and/or substance abuse (excluding nicotine and/or caffeine) within 5 years prior to screening, and/or is currently in treatment or is seeking treatment for alcohol and/or substance abuse, as assessed by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
Positive alcohol breath test at screening
Positive urine toxicology screen for drugs of abuse at screening
History of hypersensitivity, allergy, or contraindication to any opioid or clinically significant intolerance to buprenorphine or naloxone
History of seizures, convulsions, or increased intra-cranial pressure (history of pediatric febrile seizures is permitted)
History of significant head injury within 6 months of screening
Any clinically significant abnormality of the buccal mucosa which could impact drug absorption
Participation in the treatment phase of a clinical research study involving any investigational drug within 28 days (or 5 elimination half-lives, whichever is longer) of screening
Previous participation in this clinical study or any other clinical study involving BEMA buprenorphine (buprenorphine HCl buccal film)
In the Investigator's opinion at significant risk for suicidal behavior based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Hypokalemia or clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
History of myocardial infarction
Corrected QT interval (QTcF) of ≥450 milliseconds on the 12-lead ECG
History of long QT syndrome or a family member with this condition
Use of class IA antiarrhythmic medications or class III antiarrhythmic medications within 14 days of screening
Current use of α2 agonist antihypertensives (eg, clonidine), 5-HT3 antagonists (eg, ondansetron), benzodiazepines, or other medications that would be anticipated to confound detection of signs and symptoms of opioid withdrawal
Involvement in the planning and/or conduct of the study (applies to both sponsor or designee staff and staff at the study sites)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
CRI Lifetree
Philadelphia, Pennsylvania, 19139
CRI Lifetree (Lifetree Clinical Research)
Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: An Evaluation of the Tolerability of Switching Subjects on Chronic Around-the-Clock (ATC) Opioid Therapy to Buprenorphine HCl Buccal Film

Conditions: Pain
Being tested: Buprenorphine, Placebo film, Oxycodone, Morphine sulfate, Placebo capsule
Keywords: ATC, Opioid, withdrawal, switch
Medical subject headings: Pain, Ataxia Telangiectasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BuprenorphineDrug
Also called Buprenorphine buccal film, Buprenorphine HCl buccal film, EN3409, BEMA Buprenorphine
Placebo filmDrug
Also called Placebo buccal film, BEMA placebo
Matching placebo buccal film
OxycodoneDrug
Also called Oxycodone tablets, OxyContin, Oxycodone IR
Oxycodone extended-release (ER) or immediate-release (IR) 5, 10, 15, 20, and 30 mg over-encapsulated oral tablets
Morphine sulfateDrug
Also called Morphine sulfate tablets, MS Contin, Morphine sulfate IR
Morphine sulfate 15, 30, and 60 mg ER or 15 and 30 mg IR over-encapsulated oral tablets
Placebo capsuleDrug
Also called Matching placebo capsules
Oral placebo capsules matching the over-encapsulated morphine sulfate and oxycodone tablets

Study groups in NCT01871285
Study group	Role	What they receive
MSE Dose Group 1	Experimental	Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period Receives: Drug: Buprenorphine; Drug: Placebo film; Drug: Oxycodone; Drug: Morphine sulfate; Drug: Placebo capsule
MSE Dose Group 2	Experimental	Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period Receives: Drug: Buprenorphine; Drug: Placebo film; Drug: Oxycodone; Drug: Morphine sulfate; Drug: Placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Responders
A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.
Measured: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Maximum COWS Total Score
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject.
Measured: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Change From Baseline in Maximum COWS Total Score
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score.
Measured: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence

Secondary outcomes (2)

Change From Baseline in COWS Total Score Over Time
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.
Measured: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Change From Baseline in "Pain Now" Over Time Using NRS
Subject rating of pain intensity using 11-point numerical rating scale (NRS) where 0=no pain and 10=pain as bad as you can imagine.
Measured: Pre-dose (-0.5; baseline), 0.5, 1, 2, 4, 9, 12, 12.5, 13, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence

Timeline

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

Jun 2013Jul 2014

First posted6 Jun 2013 (estimated)
Study startJun 2013
Primary completionJul 2014
Study completionJul 2014

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 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 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01871285
Sponsor's protocol ID: EN3409-204
Status last verified: Jan 2017
First submitted: 4 Jun 2013
Last updated: 27 Feb 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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Tolerability of Switching Subjects on Chronic Around-the-Clock (ATC) Opioid Therapy to Buprenorphine HCl Buccal Film
ClinicalTrials.gov ID: NCT01871285
Acronym / sponsor ID: EN3409-204
Conditions: Pain
Keywords: ATC, Opioid, withdrawal, switch
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 6 Jun 2013 (estimated)
Results: Posted 3 Feb 2016

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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MSE Dose Group 1	Experimental	Drug: Buprenorphine, Drug: Placebo film, Drug: Oxycodone, Drug: Morphine sulfate, Drug: Placebo capsuleMorning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period
MSE Dose Group 2	Experimental	Drug: Buprenorphine, Drug: Placebo film, Drug: Oxycodone, Drug: Morphine sulfate, Drug: Placebo capsuleMorning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Written informed consent obtained prior to any study-related procedure being performed
Male or non-lactating female subjects 18 to 60 years of age at time of consent
Female subjects who are non-pregnant on the basis of screening serum pregnancy test and who are practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method) or have been post-menopausal, biologically sterile, or surgically sterile (ie, hysterectomy, bilateral oophorectomy, or tubal ligation) for more than 1 year
Male subjects who are practicing abstinence, surgically sterile or are using a medically acceptable form of contraception
Subjects with a ≥6 months history of chronic pain (including peripheral neuropathic pain) requiring ATC opioid therapy with ≥80 mg but ≤220 mg MSE per day for at least 28 days

Key exclusion criteria (25 listed)

Inability to meet study participation requirements, including two 2-night stays with pharmacokinetic sampling
A history or current evidence of clinically significant pulmonary (eg, asthma, chronic obstructive pulmonary disease, cor pulmonale or severe bronchial asthma ), gastrointestinal, hepatic, renal, hematologic, immunologic, endocrine, neurologic, oncologic or psychiatric disorder or any other condition, including evidence of abnormalities on physical examination, abnormal vital signs, electrocardiogram (ECG), or clinical laboratory values which in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
Supine systolic blood pressure >180 mm Hg or <90 mm Hg or diastolic blood pressure > 105 mm Hg or <50 mm Hg at screening (may be repeated once)
COWS score greater than 4 prior to the screening naloxone challenge
Aspartate aminotransferase or alanine aminotransferase >3 times the upper limits of normal or serum creatinine >1.9 mg/dL at Screening, or any laboratory abnormality which, in the opinion of the Investigator, would contraindicate study participation

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
BuprenorphineAlso: Buprenorphine buccal film, Buprenorphine HCl buccal film, EN3409, BEMA Buprenorphine	Drug	MSE Dose Group 1, MSE Dose Group 2
Placebo filmAlso: Placebo buccal film, BEMA placeboMatching placebo buccal film	Drug	MSE Dose Group 1, MSE Dose Group 2
OxycodoneAlso: Oxycodone tablets, OxyContin, Oxycodone IROxycodone extended-release (ER) or immediate-release (IR) 5, 10, 15, 20, and 30 mg over-encapsulated oral tablets	Drug	MSE Dose Group 1, MSE Dose Group 2
Morphine sulfateAlso: Morphine sulfate tablets, MS Contin, Morphine sulfate IRMorphine sulfate 15, 30, and 60 mg ER or 15 and 30 mg IR over-encapsulated oral tablets	Drug	MSE Dose Group 1, MSE Dose Group 2
Placebo capsuleAlso: Matching placebo capsulesOral placebo capsules matching the over-encapsulated morphine sulfate and oxycodone tablets	Drug	MSE Dose Group 1, MSE Dose Group 2

Primary outcome

Number of Responders
Time frame: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.
Maximum COWS Total Score
Time frame: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject.
Change From Baseline in Maximum COWS Total Score
Time frame: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score.

2 secondary outcomes

Change From Baseline in COWS Total Score Over Time
Time frame: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence
Change From Baseline in "Pain Now" Over Time Using NRS
Time frame: Pre-dose (-0.5; baseline), 0.5, 1, 2, 4, 9, 12, 12.5, 13, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence

Results and safety

Results posted to the registry on 3 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MSE Dose Group 1 (AB) - Buprenorphine (300 μg) Then ATC Opioid	18	17
MSE Dose Group 1 (BA) - ATC Opioid Then Buprenorphine (300 μg)	15	14
MSE Dose Group 2 (AB) - Buprenorphine (450 μg) Then ATC Opioid	4	3
MSE Dose Group 2 (BA) - ATC Opioid Then Buprenorphine (450 μg)	2	2

Primary outcome: Number of Responders

Time frame: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence. Number. Unit: participants

Measure	MSE Dose Group 1 - Buprenorphine n = 31	MSE Dose Group 1 - ATC Opioid n = 31	MSE Dose Group 2 - Buprenorphine n = 4	MSE Dose Group 2 - ATC Opioid n = 4
Value	1	2	0	0

Population analysed: Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS \[eg, received erroneous treatment\], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects were excluded.

Primary outcome: Maximum COWS Total Score

Measure	MSE Dose Group 1 - Buprenorphine n = 31	MSE Dose Group 1 - ATC Opioid n = 31	MSE Dose Group 2 - Buprenorphine n = 4	MSE Dose Group 2 - ATC Opioid n = 4
Value	4.6 (3.15)	5.3 (4.42)	5.5 (1.91)	6.3 (2.50)

MSE Dose Group 1 - Buprenorphine vs MSE Dose Group 1 - ATC Opioid: Mean Difference (Final Values): -0.182 (95% CI -1.60 to 1.24), p = .7942, Mixed Models Analysis
MSE Dose Group 2 - Buprenorphine vs MSE Dose Group 2 - ATC Opioid: Mean Difference (Final Values): 0.683 (95% CI -11.89 to 13.25), p = .6155, Mixed Models Analysis

Primary outcome: Change From Baseline in Maximum COWS Total Score

Time frame: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence. Mean (Standard Deviation). Unit: score

Measure	MSE Dose Group 1 - Buprenorphine n = 31	MSE Dose Group 1 - ATC Opioid n = 31	MSE Dose Group 2 - Buprenorphine n = 4	MSE Dose Group 2 - ATC Opioid n = 4
Value	4.0 (2.92)	3.9 (4.11)	4.5 (1.73)	4.3 (1.89)

MSE Dose Group 1 - Buprenorphine vs MSE Dose Group 1 - ATC Opioid: Mean Difference (Final Values): -0.182 (95% CI -1.60 to 1.24), p = .7942, Mixed Models Analysis
MSE Dose Group 2 - Buprenorphine vs MSE Dose Group 2 - ATC Opioid: Mean Difference (Final Values): 0.683 (95% CI -11.89 to 13.25), p = .6155, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening through follow-up contact 7-14 days after last dose (up to 7 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MSE Dose Group 1 - Buprenorphine	1 of 32 (3.1%)	18 of 32 (56.3%)	Not reported
MSE Dose Group 1 - ATC Opioid	0 of 32 (0%)	13 of 32 (40.6%)	Not reported
MSE Dose Group 2 - Buprenorphine	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MSE Dose Group 2 - ATC Opioid	0 of 5 (0%)	0 of 5 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 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.

Todd Kirby, PhD study director

Endo USA Inc., a Keenova Therapeutics Company

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 Buprenorphine, Oxycodone and Morphine sulfate in people with Pain, run by BioDelivery Sciences International 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 9 inclusion and 25 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 27 Feb 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. 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 3 Feb 2016). 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?

Number of Responders (time frame: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence). The study lists 3 primary outcomes in all. 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 NCT01871285.

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 27 Feb 2017.