Back PainPhase 2NCT01415895
Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain
A Phase 2 study testing Naltrexone and Clonidine Combination in people with Back Pain and Lower Back Pain, run by Annette C. Toledano MD at 1 site in United States.
Trial summary
The study includes back pain of the cervical, thoracic, and the lumbar regions. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Back Pain, Lower Back Pain, Cervical Pain
- What is being tested?
- Naltrexone and Clonidine Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The study includes back pain of the cervical, thoracic, and the lumbar regions.
- Conditions
- Back Pain, Lower Back Pain, Cervical Pain
- Being tested
- Naltrexone and Clonidine Combination, placebo
- Keywords
- back pain, cervical pain, neuropathic pain, radicular pain
- Medical subject headings
- Back Pain, Low Back Pain, Neck Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone and Clonidine CombinationDrug
Also called ATNC05
subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
placeboDrug
subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| ATNC05 - a study drug capsule | Experimental | Naltrexone and Clonidine Combination (ATNC05) Receives: Drug: Naltrexone and Clonidine Combination |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline to week 3
Secondary outcomes (18)
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).
Measured: baseline to week 1, week 2 and week 3
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).
Measured: baseline to week 1, week 2 and week 3
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)
Measured: baseline to week 1, week 2 and week 3
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)
Measured: baseline to week 1, week 2 and week 3
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.
Measured: baseline to week 1, week 2 and week 3
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).
Measured: baseline to week 1, week 2 and week 3
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.
Measured: baseline 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
Measured: baseline to week 1, week 2 and week 3
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.
Measured: baseline to week 1, week 2 and week 3
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.
Measured: baseline to week 1, week 2 and week 3
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
Measured: baseline to week 1, week 2 and week 3
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%
Measured: baseline to week 1, week 2 and week 3
Subject's response to the question, "Have you responded to the treatment?"
Subject's answer yes/no.
Measured: baseline to week 1, week 2 and week 3
Subject's Global Assessment of Disease Activity Improved / No Change
The Subject answer either Improved or No Change.
Measured: baseline to week 1, week 2 and week 3
Subject's Global Evaluation of Study Medication.
The subject chooses, 1 - Excellent, 2 - Very Good, 3 - Good, 4 - Fair, 5 - Poor
Measured: baseline to week 1, week 2 and week 3
The Subject's Satisfaction with Pain Relief, 0 - 10.
The subject answers on a scale of 0-10, (0 - not satisfied, 10 - very satisfied).
Measured: baseline to week 1, week 2 and week 3
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)
Measured: baseline to week 1, week 2 and week 3.
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).
Measured: baseline to week 1, week 2 and week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Annette C. Toledano MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Annette C. Toledano MD, Allodynic Therapeutics, Inc
- Investigators
- Annette C Toledano, MD, Principal investigator, Allodynic Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415895
- Sponsor's protocol ID
- AT110491
- Status last verified
- Apr 2021
- First submitted
- 11 Aug 2011
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01415895
- Acronym / sponsor ID
- AT110491
- Conditions
- Back Pain, Lower Back Pain, Cervical Pain
- Keywords
- back pain, cervical pain, neuropathic pain, radicular pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Annette C. Toledano MDIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study includes back pain of the cervical, thoracic, and the lumbar regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATNC05 - a study drug capsule | Experimental | Drug: Naltrexone and Clonidine CombinationNaltrexone and Clonidine Combination (ATNC05) |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Naltrexone and Clonidine CombinationAlso: ATNC05subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days. | Drug | ATNC05 - a study drug capsule |
| placebosubjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days. | Drug | placebo |
Primary outcome
Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for average pain (Question #5)
Time frame: baseline to week 3
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).
18 secondary outcomes
Change from Baseline in Brief Pain Inventory 24-hour assessment of interference in function (Questions 9a - 9i).
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in Brief Pain Inventory 24-hour subject's Global Impression of Improvement (Question 8)
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in the subject's Global Assessment of Treatment Satisfaction today
Time frame: baseline to week 1, week 2 and week 3
Change from Baseline in the subject's perception of Ability to Tolerate the study drug and the severity of side effects today.
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in Oswestry Disability Index and Neck Disability composite scores(ODI), to Week 1, Week 2, and Week 3
Time frame: baseline to week 1, week 2 and week 3
Change From Baseline in Roland Morris Disability Questionnaire composite scores(ODI), to Week 1, Week 2, and Week 3
Time frame: baseline to week 1, week 2 and week 3
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
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
Change from Baseline in the investigator's Clinical Global Impression - Severity scale (CGI-S) to Week 1, Week 2, week 3 .
Time frame: baseline to week 1, week 2 and week 3
Change from Baseline in The investigator's Clinical Global Impression - Improvement scale (CGI-I) to Week 1, Week 2, week 3
Time frame: baseline to week 1, week 2 and week 3
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?
Time frame: baseline to week 1, week 2 and week 3
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 %.
Time frame: baseline to week 1, week 2 and week 3
Subject's response to the question, "Have you responded to the treatment?"
Time frame: baseline to week 1, week 2 and week 3
Subject's Global Assessment of Disease Activity Improved / No Change
Time frame: baseline to week 1, week 2 and week 3
Subject's Global Evaluation of Study Medication.
Time frame: baseline to week 1, week 2 and week 3
The Subject's Satisfaction with Pain Relief, 0 - 10.
Time frame: baseline to week 1, week 2 and week 3
The Subject's Satisfaction with Moving, Standing, Walking and Bending Ability Scale, 0-10.
Time frame: baseline to week 1, week 2 and week 3.
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)
Time frame: baseline to week 1, week 2 and week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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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.
Annette C Toledano, MD principal investigator
Allodynic Therapeutics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone and Clonidine Combination in people with Back Pain and Lower Back Pain, run by Annette C. Toledano MD at 1 site 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 8 inclusion and 4 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for average pain (Question #5) (time frame: baseline to week 3). 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 14 Apr 2021.