Back to resultsNaltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain
Primary Purpose
Back Pain, Lower Back Pain, Cervical Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone and Clonidine Combination
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring back pain, cervical pain, neuropathic pain, radicular pain
Eligibility Criteria
Inclusion Criteria:
The subject has chronic back pain for > 3 months in the lumbar, thoracic or cervical regions.
The average pain intensity scale during the screening week is 4/10 - 8/10 (On an 11-point Numeric Pain Intensity Scale with 0 = no pain and 10 = worst pain imaginable).
The subject has not taken Opioid medications 7 days prior to initiation of study drug.
The subject has a heart rate of 60bpm or above and/or systolic blood pressure 90 or above.
The subject is willing to refrain from using NSAIDS, Acetaminophen or muscle relaxants, unless for rescue, for the duration of the study The subject is willing to refrain from using Opioid medications and excessive alcohol for the duration of the study.
The subject is able to read, understand and follow the study instructions, including completion of questionnaires at home.
The subject must sign an informed consent document indicating willingness to participate.
If the subject is a female, she must be post-menopausal, not currently pregnant or nursing. A female of child bearing potential should be using a reliable contraception method during the course of the study.
Exclusion Criteria:
The subject has a positive urine drug screen. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
The subject has any significant deviations from normal in physical examination, electrocardiogram (ECG), Echocardiogram or clinical laboratory tests, as evaluated by the investigator.
The subject has a history of an allergic reaction to the components of the study drug.
The subject has acute back or cervical pain. The subject has muscular back or cervical pain. The subject has back or cervical pain other than chronic Radicular pain.
Sites / Locations
- Annette C. Toledano MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ATNC05 - a study drug capsule
placebo
Arm Description
Naltrexone and Clonidine Combination (ATNC05)
Outcomes
Primary Outcome Measures
Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for average pain (Question #5)
The Brief Pain Inventory is a self-reported medical questionnaire used to measure pain over the past 24-hours - worst pain (Question 3), least pain (Question 4), average pain (Question 5), right now pain (Question 6) and at night pain (Question 7). The score ranges from 0 to 10 (0 - no pain) (10 - intolerable pain).
Secondary Outcome Measures
Change from Baseline in Brief Pain Inventory 24-hour assessment of interference in function (Questions 9a - 9i).
BPI Interference; questions 9a - 9i - measures a self-reported assessment of the interference in function because of pain in past 24 hours in general activity, mood, walking ability, normal work, relationship with other people, sleep quality, enjoyment of life, standing ability and sitting ability. Interference scores: 0 (does not interfere) to 10 (completely interferes).
Change From Baseline in Brief Pain Inventory 24-hour subject's Global Impression of Improvement (Question 8)
The Brief Pain Inventory question 8 measures the subject's perception of how much relief he has received at the time of assessment compared with before the start of the study drug. The score is measured in percentage 0% (no relief) to100% (complete relief).
Change From Baseline in the subject's Global Assessment of Treatment Satisfaction today
A self-reported scale that measures Treatment Satisfaction today in (0-10, 0 - none, 10 - most satisfied)
Change from Baseline in the subject's perception of Ability to Tolerate the study drug and the severity of side effects today.
A self-reported scale that measures the ability to tolerate the study drug and the severity of side effects today in (0-10, 0 - No side effects, 10 - intolerable side effects)
Change From Baseline in Oswestry Disability Index and Neck Disability composite scores(ODI), to Week 1, Week 2, and Week 3
The Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index) and Neck Disability composite assesses pain-related disability in persons with low back pain (LBP) and neck pain. The score is recorded in percentage of disability.
Change From Baseline in Roland Morris Disability Questionnaire composite scores(ODI), to Week 1, Week 2, and Week 3
The Roland Morris Disability Questionnaire consists of 24 statements and the subject is instructed to put a mark next to each appropriate statement. The total score ranges from 0 (no disability) to 24 (severe disability).
Change From Baseline in Vital Signs - systolic blood pressure, diastolic blood pressure, pulse rate and body mass index to Week 1, Week 2, and Week 3.
Change from Baseline to week 3 in Laboratory Assessments - Alkaline Phosphatase, Alanine Transaminase - ALT (SGPT), Aspartate transaminase - AST(SGOT), Bilirubin, Total, Serum Creatinine, Blood Urea Nitrogen, Serum Chloride, Potassium, HCO3
Change from Baseline in the investigator's Clinical Global Impression - Severity scale (CGI-S) to Week 1, Week 2, week 3 .
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the investigator to rate the severity of the subject's back pain at the time of assessment, relative to the investigator's past experience. Considering total clinical experience, the subject is assessed on severity of back pain at the time of rating 1, normal; 2, borderline; 3, mild; 4, moderate; 5, marked; 6, severe; or 7, extreme.
Change from Baseline in The investigator's Clinical Global Impression - Improvement scale (CGI-I) to Week 1, Week 2, week 3
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale, the investigator will rate how much the patient's back pain has improved or worsened relative to a baseline state at the beginning of the study and rate as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Change from Baseline in the subject's answer to the question, "Are you better off today then the time before starting the study drug?, yes/no, by what percentage?
Answer, yes/no and by 0%-100% (0%-not at all better, 100% - very much better off
Change From Baseline in the subject's answer to the question " Have you been more / less active in the past 24 hrs, comparing to the period before initiating the study drug, please rate in %.
The subjects answer, one of the following choices, - 150%, -100%, -50%, - 25%, 0% - same activity level, +25%, +50%, +100%, +150%
Subject's response to the question, "Have you responded to the treatment?"
Subject's answer yes/no.
Subject's Global Assessment of Disease Activity Improved / No Change
The Subject answer either Improved or No Change.
Subject's Global Evaluation of Study Medication.
The subject chooses, 1 - Excellent, 2 - Very Good, 3 - Good, 4 - Fair, 5 - Poor
The Subject's Satisfaction with Pain Relief, 0 - 10.
The subject answers on a scale of 0-10, (0 - not satisfied, 10 - very satisfied).
The Subject's Satisfaction with Moving, Standing, Walking and Bending Ability Scale, 0-10.
The subjects answers on a scale of 0-10, (0 - not satisfied, 10 - very satisfied)
Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for worst pain, least pain, right now pain and night pain (Questions 3,4,6 & 7)
The Brief Pain Inventory is a self-reported medical questionnaire used to measure pain over the past 24-hours - worst pain (Question 3), least pain (Question 4), average pain (Question 5), right now pain (Question 6) and at night pain (Question 7). The score ranges from 0 to 10 (0 - no pain) (10 - intolerable pain).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01415895
Brief Title
Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain
Official Title
A Proof-of-Concept, Randomized, Double-Blind and Placebo Controlled Clinical Trial With Naltrexone and Clonidine Combination (ATNC05) Compared With Placebo in the Treatment of Chronic Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Annette C. Toledano MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study includes back pain of the cervical, thoracic, and the lumbar regions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Lower Back Pain, Cervical Pain
Keywords
back pain, cervical pain, neuropathic pain, radicular pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATNC05 - a study drug capsule
Arm Type
Experimental
Arm Description
Naltrexone and Clonidine Combination (ATNC05)
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone and Clonidine Combination
Other Intervention Name(s)
ATNC05
Intervention Description
subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
Primary Outcome Measure Information:
Title
Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for average pain (Question #5)
Description
The Brief Pain Inventory is a self-reported medical questionnaire used to measure pain over the past 24-hours - worst pain (Question 3), least pain (Question 4), average pain (Question 5), right now pain (Question 6) and at night pain (Question 7). The score ranges from 0 to 10 (0 - no pain) (10 - intolerable pain).
Time Frame
baseline to week 3
Secondary Outcome Measure Information:
Title
Change from Baseline in Brief Pain Inventory 24-hour assessment of interference in function (Questions 9a - 9i).
Description
BPI Interference; questions 9a - 9i - measures a self-reported assessment of the interference in function because of pain in past 24 hours in general activity, mood, walking ability, normal work, relationship with other people, sleep quality, enjoyment of life, standing ability and sitting ability. Interference scores: 0 (does not interfere) to 10 (completely interferes).
Time Frame
baseline to week 1, week 2 and week 3
Title
Change From Baseline in Brief Pain Inventory 24-hour subject's Global Impression of Improvement (Question 8)
Description
The Brief Pain Inventory question 8 measures the subject's perception of how much relief he has received at the time of assessment compared with before the start of the study drug. The score is measured in percentage 0% (no relief) to100% (complete relief).
Time Frame
baseline to week 1, week 2 and week 3
Title
Change From Baseline in the subject's Global Assessment of Treatment Satisfaction today
Description
A self-reported scale that measures Treatment Satisfaction today in (0-10, 0 - none, 10 - most satisfied)
Time Frame
baseline to week 1, week 2 and week 3
Title
Change from Baseline in the subject's perception of Ability to Tolerate the study drug and the severity of side effects today.
Description
A self-reported scale that measures the ability to tolerate the study drug and the severity of side effects today in (0-10, 0 - No side effects, 10 - intolerable side effects)
Time Frame
baseline to week 1, week 2 and week 3
Title
Change From Baseline in Oswestry Disability Index and Neck Disability composite scores(ODI), to Week 1, Week 2, and Week 3
Description
The Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index) and Neck Disability composite assesses pain-related disability in persons with low back pain (LBP) and neck pain. The score is recorded in percentage of disability.
Time Frame
baseline to week 1, week 2 and week 3
Title
Change From Baseline in Roland Morris Disability Questionnaire composite scores(ODI), to Week 1, Week 2, and Week 3
Description
The Roland Morris Disability Questionnaire consists of 24 statements and the subject is instructed to put a mark next to each appropriate statement. The total score ranges from 0 (no disability) to 24 (severe disability).
Time Frame
baseline to week 1, week 2 and week 3
Title
Change From Baseline in Vital Signs - systolic blood pressure, diastolic blood pressure, pulse rate and body mass index to Week 1, Week 2, and Week 3.
Time Frame
baseline to week 1, week 2 and week 3
Title
Change from Baseline to week 3 in Laboratory Assessments - Alkaline Phosphatase, Alanine Transaminase - ALT (SGPT), Aspartate transaminase - AST(SGOT), Bilirubin, Total, Serum Creatinine, Blood Urea Nitrogen, Serum Chloride, Potassium, HCO3
Time Frame
baseline to week 1, week 2 and week 3
Title
Change from Baseline in the investigator's Clinical Global Impression - Severity scale (CGI-S) to Week 1, Week 2, week 3 .
Description
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the investigator to rate the severity of the subject's back pain at the time of assessment, relative to the investigator's past experience. Considering total clinical experience, the subject is assessed on severity of back pain at the time of rating 1, normal; 2, borderline; 3, mild; 4, moderate; 5, marked; 6, severe; or 7, extreme.
Time Frame
baseline to week 1, week 2 and week 3
Title
Change from Baseline in The investigator's Clinical Global Impression - Improvement scale (CGI-I) to Week 1, Week 2, week 3
Description
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale, the investigator will rate how much the patient's back pain has improved or worsened relative to a baseline state at the beginning of the study and rate as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time Frame
baseline to week 1, week 2 and week 3
Title
Change from Baseline in the subject's answer to the question, "Are you better off today then the time before starting the study drug?, yes/no, by what percentage?
Description
Answer, yes/no and by 0%-100% (0%-not at all better, 100% - very much better off
Time Frame
baseline to week 1, week 2 and week 3
Title
Change From Baseline in the subject's answer to the question " Have you been more / less active in the past 24 hrs, comparing to the period before initiating the study drug, please rate in %.
Description
The subjects answer, one of the following choices, - 150%, -100%, -50%, - 25%, 0% - same activity level, +25%, +50%, +100%, +150%
Time Frame
baseline to week 1, week 2 and week 3
Title
Subject's response to the question, "Have you responded to the treatment?"
Description
Subject's answer yes/no.
Time Frame
baseline to week 1, week 2 and week 3
Title
Subject's Global Assessment of Disease Activity Improved / No Change
Description
The Subject answer either Improved or No Change.
Time Frame
baseline to week 1, week 2 and week 3
Title
Subject's Global Evaluation of Study Medication.
Description
The subject chooses, 1 - Excellent, 2 - Very Good, 3 - Good, 4 - Fair, 5 - Poor
Time Frame
baseline to week 1, week 2 and week 3
Title
The Subject's Satisfaction with Pain Relief, 0 - 10.
Description
The subject answers on a scale of 0-10, (0 - not satisfied, 10 - very satisfied).
Time Frame
baseline to week 1, week 2 and week 3
Title
The Subject's Satisfaction with Moving, Standing, Walking and Bending Ability Scale, 0-10.
Description
The subjects answers on a scale of 0-10, (0 - not satisfied, 10 - very satisfied)
Time Frame
baseline to week 1, week 2 and week 3.
Title
Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for worst pain, least pain, right now pain and night pain (Questions 3,4,6 & 7)
Description
The Brief Pain Inventory is a self-reported medical questionnaire used to measure pain over the past 24-hours - worst pain (Question 3), least pain (Question 4), average pain (Question 5), right now pain (Question 6) and at night pain (Question 7). The score ranges from 0 to 10 (0 - no pain) (10 - intolerable pain).
Time Frame
baseline to week 1, week 2 and week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject has chronic back pain for > 3 months in the lumbar, thoracic or cervical regions.
The average pain intensity scale during the screening week is 4/10 - 8/10 (On an 11-point Numeric Pain Intensity Scale with 0 = no pain and 10 = worst pain imaginable).
The subject has not taken Opioid medications 7 days prior to initiation of study drug.
The subject has a heart rate of 60bpm or above and/or systolic blood pressure 90 or above.
The subject is willing to refrain from using NSAIDS, Acetaminophen or muscle relaxants, unless for rescue, for the duration of the study The subject is willing to refrain from using Opioid medications and excessive alcohol for the duration of the study.
The subject is able to read, understand and follow the study instructions, including completion of questionnaires at home.
The subject must sign an informed consent document indicating willingness to participate.
If the subject is a female, she must be post-menopausal, not currently pregnant or nursing. A female of child bearing potential should be using a reliable contraception method during the course of the study.
Exclusion Criteria:
The subject has a positive urine drug screen. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
The subject has any significant deviations from normal in physical examination, electrocardiogram (ECG), Echocardiogram or clinical laboratory tests, as evaluated by the investigator.
The subject has a history of an allergic reaction to the components of the study drug.
The subject has acute back or cervical pain. The subject has muscular back or cervical pain. The subject has back or cervical pain other than chronic Radicular pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette C Toledano, MD
Organizational Affiliation
Allodynic Therapeutics, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Annette C. Toledano MD
City
North Miami
State/Province
Florida
ZIP/Postal Code
33181
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain
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