Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence

• Sponsor: Braeburn Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02651584
• Collaborator: (none)
• Enrollment: 428
• Locations: 36
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 11.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorders	Drug: CAM2038 SC injection; Drug: SL BPN/NX tabs; Drug: placebo SC injections; Drug: SL placebo tablets	Phase 3

Detailed Description

This is a Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN. The trial will involve 4 phases: Screening, Phase 1 (weekly visits), Phase 2 (monthly visits), and Follow-up.

Approximately 380 subjects (190 subjects per arm) will be randomized.

Study Design

• Study Type: Interventional
• Actual Enrollment: 428 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel Group, Multi-center Trial Assessing the Efficacy and Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) in Treatment of Adult Outpatients With Opioid Use Disorder
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SL BPN/NX tabs + placebo SC injections SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day. CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).	Drug: SL BPN/NX tabs; Other Names: Suboxone ; Drug: placebo SC injections; Other Names: placebo
Experimental: CAM2038 SC injections + SL placebo tabs CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 or 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection). CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection). SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily	Drug: CAM2038 SC injection; Other Names: Buprenorphine injection ; Drug: SL placebo tablets; Other Names: placebo

Outcome Measures

Primary Outcome Measures

1. Response Rate, Denoted by Response Rate (Weeks 1-24). [24 weeks]

   Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use.

Secondary Outcome Measures

1. Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids [24 weeks]

   Cumulative distribution function (CDF) of percentage of urine samples negative for illicit opioids comparing CAM2038 to SL BPN/NX as (supported by self-reported opioid use results)

2. Number of Subjects With Sustained Abstinence of Opioid Use [24 weeks]

   Number of Subjects with Sustained Abstinence of Opioid Use taking SL BPN/NX and CAM2038

3. Number of Subjects Remaining in the Study (Retention Rate) [24 weeks]

   Number of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject must provide written informed consent prior to the conduct of any trial-related procedures.

2. Male or female, 18-65 years of age, inclusive.

3. Diagnosis of moderate or severe opioid use disorder as described (DSM-V).

4. Voluntarily seeking treatment for opioid use disorder.

5. Have not received medication-assisted treatment for opioid use disorder within 60 days prior to randomization.

6. Considered by the Investigator to be a good candidate for BPN treatment, based on medical and psychosocial history.

7. Male or Female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire trial (Screening visit to Follow-up visit)

Exclusion Criteria:

1. Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS).

2. Current diagnosis of chronic pain requiring opioids for treatment.

3. Current DSM-V diagnosis of moderate to severe substance use disorder on any other psychoactive substances other than opioids, caffeine or nicotine (e.g., alcohol, cocaine, sedatives).

4. Pregnant or lactating or planning to become pregnant during the trial.

5. Hypersensitivity or allergy to BPN or other opioids, naloxone or other opioid antagonists, or excipients of CAM2038 or SL BPN.

6. Requires current use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir).

7. Subjects with active signs or symptoms of hepatitis and requiring treatment. Subjects with no acute signs of inflammation, and no clinical necessity for therapy will be allowed, at the discretion of the Investigator.

8. Recent history of or current evidence of suicidal ideation or active suicidal behavior as based on the Columbia Suicide Severity Rating Scale (C-SSRS) ("Yes" responses to questions 4 or 5).

9. Any pending legal action that could prohibit participation or compliance in the trial.

10. Exposure to any investigational drug within the 4 weeks prior to Screening.

11. Participants with a history of risk factors of Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or an electrocardiogram (ECG) demonstrating a Fridericia's corrected QT interval (QTcF) >450 msec in males and QTcF >470 in females at screening.

12. Aspartate aminotransferase (AST) levels >3 X the upper limit of normal, alanine aminotransferase (ALT) levels >3 X the upper limit of normal, total bilirubin >1.5 X the upper limit of normal, or creatinine >1.5 X upper limit of normal on the Screening laboratory assessments, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the subject from safely participating in trial.

13. Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the trial or obtaining informed consent, or may prevent the subject from safely participating in trial (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator's Brochure for CAM2038).

14. Is an employee of the Investigator or the trial site, with direct involvement in the proposed trial or other trials under the direction of the Investigator or trial site, or is a family member of an employee or of the Investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkway Medical Center	Birmingham	Alabama	United States	35215
2	Haleyville Clinical Research LLC	Haleyville	Alabama	United States	35565
3	Boyett Health Services Inc	Hamilton	Alabama	United States	35570
4	Synergy East	Lemon Grove	California	United States	91945
5	North County Clinical Research	Oceanside	California	United States	92056
6	Asclepes Research	Panorama City	California	United States	91402
7	Artemis Institute for Clinical Research	San Diego	California	United States	92103
8	Care Practice	San Francisco	California	United States	94708
9	Synergist Research	West Hollywood	California	United States	90046
10	Dr Vijapura and Associates	Jacksonville	Florida	United States	32256
11	Innovative Clinical Research Inc	Lauderhill	Florida	United States	33319
12	TRY Research	Maitland	Florida	United States	32751
13	Tellus Clinical Research, Inc.	Miami	Florida	United States	33173
14	Scientific Clinical Research, Inc.	North Miami	Florida	United States	33161
15	Professional Research Network of Kansas, LLC	Wichita	Kansas	United States	67203
16	University of Kentucky Medical Center	Lexington	Kentucky	United States	40508
17	Stanley Street Treatment and Resources Inc	Fall River	Massachusetts	United States	02720
18	Novex Clinical Research	New Bedford	Massachusetts	United States	02740
19	Precise Research Centers	Flowood	Mississippi	United States	39232
20	PsychCare Consultants Research	Saint Louis	Missouri	United States	63128
21	St. Louis Clinical Trials	Saint Louis	Missouri	United States	63141
22	Wellness and Research Center	Belvidere	New Jersey	United States	07823
23	Comprehensive Clinical Research	Berlin	New Jersey	United States	08009
24	STARS/Columbia University	New York	New York	United States	10019
25	Neuro-Behavioral Clinical Research Center	Canton	Ohio	United States	44718
26	Midwest Clinical Research Center	Dayton	Ohio	United States	45417
27	North Star Medical Research	Middleburg Heights	Ohio	United States	44130
28	Rivus Wellness & Research Institute	Oklahoma City	Oklahoma	United States	73112
29	Frost Medical Group	Conshohocken	Pennsylvania	United States	19428
30	The University of Pennsylvania Health System Treatment Research Center	Philadelphia	Pennsylvania	United States	19104
31	Lincoln Research	Lincoln	Rhode Island	United States	02865
32	Carolina Clinical Trials, Inc	Charleston	South Carolina	United States	29407
33	InSite Clinical Research	Dallas	Texas	United States	75115
34	Aspen Clinical Research	Orem	Utah	United States	84058
35	University of Vermont	Burlington	Vermont	United States	05401
36	Swedish Health Services	Seattle	Washington	United States	98107

Sponsors and Collaborators

• Braeburn Pharmaceuticals

Investigators

• Study Chair: Braeburn Pharmaceuticals, Braeburn Pharmaceuticals

Study Documents (Full-Text)

• Statistical Analysis Plan - Nov 4, 2016
• Study Protocol - Nov 3, 2016

More Information

Publications

None provided.

• Responsible Party: Braeburn Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02651584
• Other Study ID Numbers: HS-11-421
• First Posted: Jan 11, 2016
• Last Update Posted: Aug 22, 2019
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Opioid-Related Disorders; Buprenorphine

Study Results

Participant Flow

Arm/Group Title	Group 1: SL BPN Tablets + Placebo Subcutaneous (SC) Injections	Group 2: CAM2038 SC Injections + SL Placebo Tablets
Arm/Group Description	SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day. CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).	CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection). CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection). SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
Period Title: Overall Study
STARTED	215	213
COMPLETED	126	121
NOT COMPLETED	89	92

Baseline Characteristics

Arm/Group Title	Group 1: SL BP/NX Tablets + Placebo SC Injections	Group 2: CAM2038 SC Injections + SL Placebo Tablets	Total
Arm/Group Description	SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day. CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).	CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection). CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection). SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily	Total of all reporting groups
Overall Participants	215	213	428
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.0 (10.89)	38.7 (11.17)	38.4 (11.02)
Sex: Female, Male (Count of Participants)
Female	73 34%	92 43.2%	165 38.6%
Male	142 66%	121 56.8%	263 61.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.5%	2 0.9%	3 0.7%
Asian	0 0%	1 0.5%	1 0.2%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.5%	1 0.2%
Black or African American	48 22.3%	47 22.1%	95 22.2%
White	164 76.3%	159 74.6%	323 75.5%
More than one race	2 0.9%	3 1.4%	5 1.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	24 11.2%	25 11.7%	49 11.4%
Not Hispanic or Latino	191 88.8%	188 88.3%	379 88.6%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.2 (5.55)	25.6 (5.03)	25.9 (5.30)

Outcome Measures

1. Primary Outcome

Title	Response Rate, Denoted by Response Rate (Weeks 1-24).
Description	Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Includes all subjects who were randomized and receiving at least one dose of study drug.

Arm/Group Title	Group 1: SL BP/NX Tablets + Placebo SC Injections	Group 2: CAM2038 SC Injections + SL Placebo Tablets
Arm/Group Description	SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day. CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).	CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection). CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection). SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
Measure Participants	215	213
Responder	31 14.4%	37 17.4%
Non-Responder	184 85.6%	176 82.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: SL BP/NX Tablets + Placebo SC Injections, Group 2: CAM2038 SC Injections + SL Placebo Tablets
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The p-value was based on the chi square test for non-inferiority with the margin of 10% point.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids
Description	Cumulative distribution function (CDF) of percentage of urine samples negative for illicit opioids comparing CAM2038 to SL BPN/NX as (supported by self-reported opioid use results)
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

Includes all subjects who were randomized and receiving at least one dose of study drug.

Arm/Group Title	SL BPN Tablets + Placebo Subcutaneous (SC) Injections	Group 2: CAM2038 SC Injections + SL Placebo Tablets
Arm/Group Description	SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day. CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).	CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection). CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection). SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
Measure Participants	215	213
With Subjects' Self Reported Opioid Use	0.0	26.7
Without Subjects' Self reported Opioid Use	6.7	26.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: SL BP/NX Tablets + Placebo SC Injections, Group 2: CAM2038 SC Injections + SL Placebo Tablets
	Comments	including subject self-reported opioid use
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Wilcoxon Rank-Sum
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 1: SL BP/NX Tablets + Placebo SC Injections, Group 2: CAM2038 SC Injections + SL Placebo Tablets
	Comments	not including self-reported opioid use
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	Wilcoxon Rank-Sum
	Comments

3. Secondary Outcome

Title	Number of Subjects With Sustained Abstinence of Opioid Use
Description	Number of Subjects with Sustained Abstinence of Opioid Use taking SL BPN/NX and CAM2038
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: SL BPN/NX Tabs+ Placebo Subcutaneous (SC) Injections	Group 2: CAM2038 SC Injections + SL Placebo Tablets
Arm/Group Description	SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day. CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).	CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection). CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection). SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
Measure Participants	215	213
Subjects with sustained abstinence of opioids	30 14%	39 18.3%
Subjects without sustained abstinence of opioids	185 86%	174 81.7%

4. Secondary Outcome

Title	Number of Subjects Remaining in the Study (Retention Rate)
Description	Number of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: SL BPN/NX Tablets + Placebo SC Injections	Group 2: CAM2038 SC Injections + SL Placebo Tablets
Arm/Group Description	SL BPN/NX: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day. CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).	CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection). CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection). SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
Measure Participants	215	213
Retained	126 58.6%	121 56.8%
Not Retained	89 41.4%	92 43.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: SL BP/NX Tablets + Placebo SC Injections, Group 2: CAM2038 SC Injections + SL Placebo Tablets
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The p-value was based on the chi square test for non-inferiority with the margin of 15%.
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	31 weeks
Arm/Group Title	Group 1: SL BPN/NX Tablets + Placebo SC Injections		Group 2: CAM2038 SC Injections + SL Placebo Tablets
Arm/Group Description	SL BPN: 2 mg/0.5 mg or 8 mg/2 mg BPN/naloxone tablets administered daily, at doses of 8 mg/2 mg to 32 mg/8 mg per day. CAM2038 placebo: 0.16, 0.32, 0.48 and 0.64 mL SC injection administered once weekly or once monthly (matching volumes for CAM2038 q1w and near-matching volumes for CAM2038 q4w).		CAM2038 q1w: BPN FluidCrystal® SC injection depot for once weekly administration (50 mg/mL) at doses of 8, 16, 24 and 32 mg (BPN base) (0.16, 0.32, 0.48 or 0.64 mL SC injection). CAM2038 q4w: BPN FluidCrystal® SC injection depot for once monthly administration (356 mg/mL) at doses of 64, 96, 128 or 160 mg (BPN base) (0.18, 0.27, 0.36 or 0.45 mL SC injection). SL placebo: tablets matching 2 mg/0.5 mg and 8 mg/2 mg SL BPN doses, administered daily
All Cause Mortality
	Group 1: SL BPN/NX Tablets + Placebo SC Injections		Group 2: CAM2038 SC Injections + SL Placebo Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/215 (0%)		1/213 (0.5%)
Serious Adverse Events
	Group 1: SL BPN/NX Tablets + Placebo SC Injections		Group 2: CAM2038 SC Injections + SL Placebo Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/215 (7.4%)		5/213 (2.3%)
Congenital, familial and genetic disorders
Haemophilia	1/215 (0.5%)	1	0/213 (0%)	0
Gastrointestinal disorders
Vomiting	0/215 (0%)	0	1/213 (0.5%)	1
General disorders
Non-cardiac Chest Pain	0/215 (0%)	0	1/213 (0.5%)	1
Infections and infestations
Abscess limb	1/215 (0.5%)	1	0/213 (0%)	0
Acute Hepatitis C	1/215 (0.5%)	1	0/213 (0%)	0
Cellulitis	1/215 (0.5%)	1	0/213 (0%)	0
Osteomyelitis	1/215 (0.5%)	1	0/213 (0%)	0
Pneumonia	1/215 (0.5%)	1	0/213 (0%)	0
Sepsis	1/215 (0.5%)	1	0/213 (0%)	0
Localized infection	1/215 (0.5%)	1	0/213 (0%)	0
Subcutaneous abscess	1/215 (0.5%)	1	0/213 (0%)	0
Injury, poisoning and procedural complications
Accidental Overdose	3/215 (1.4%)	3	0/213 (0%)	0
Intentional Overdose	1/215 (0.5%)	1	0/213 (0%)	0
Road traffic accident	0/215 (0%)	0	1/213 (0.5%)	1
Nervous system disorders
Seizure	1/215 (0.5%)	1	0/213 (0%)	0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/215 (0%)	0	1/213 (0.5%)	1
Psychiatric disorders
Bipolar disorder	1/215 (0.5%)	1	0/213 (0%)	0
Substance-induce mood disorder	1/215 (0.5%)	1	0/213 (0%)	0
Suicidal Ideation	1/215 (0.5%)	1	1/213 (0.5%)	1
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disorder	1/215 (0.5%)	1	0/213 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1: SL BPN/NX Tablets + Placebo SC Injections		Group 2: CAM2038 SC Injections + SL Placebo Tablets
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	119/215 (55.3%)		128/213 (60.1%)
Cardiac disorders
Tachycardia	5/215 (2.3%)	5	5/213 (2.3%)	5
Gastrointestinal disorders
Constipation	16/215 (7.4%)	16	16/213 (7.5%)	16
Nausea	17/215 (7.9%)	17	15/213 (7%)	15
Vomiting	8/215 (3.7%)	8	9/213 (4.2%)	9
Diarrhoea	7/215 (3.3%)	7	6/213 (2.8%)	6
Toothache	8/215 (3.7%)	8	3/213 (1.4%)	3
General disorders
Injection site pain	17/215 (7.9%)	17	19/213 (8.9%)	19
Injection site pruritus	13/215 (6%)	13	13/213 (6.1%)	13
Injection site erythema	12/215 (5.6%)	12	12/213 (5.6%)	12
Injection site reaction	7/215 (3.3%)	7	8/213 (3.8%)	8
Injection site swelling	6/215 (2.8%)	6	9/213 (4.2%)	9
Injection site induration	6/215 (2.8%)	6	4/213 (1.9%)	4
Injection site inflammation	8/215 (3.7%)	8	2/213 (0.9%)	2
Infections and infestations
Urinary tract infection	10/215 (4.7%)	10	11/213 (5.2%)	11
Upper respiratory tract infection	9/215 (4.2%)	9	9/213 (4.2%)	9
Cellulitis	7/215 (3.3%)	7	1/213 (0.5%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	3/215 (1.4%)	3	7/213 (3.3%)	7
Back Pain	6/215 (2.8%)	6	3/213 (1.4%)	3
Musculoskeletal Pain	5/215 (2.3%)	5	0/213 (0%)	0
Nervous system disorders
Headache	17/215 (7.9%)	17	16/213 (7.5%)	16
Psychiatric disorders
Insomnia	6/215 (2.8%)	6	12/213 (5.6%)	12
Anxiety	7/215 (3.3%)	7	6/213 (2.8%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.