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Completed

NCT Number: NCT01415895

Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain

The study includes back pain of the cervical, thoracic, and the lumbar regions.

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Key information

Conditions

Back Pain Cervical Pain Low Back Pain Lower Back Pain Neck Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Annette C. Toledano MD

North Miami, Florida, 33181, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naltrexone and Clonidine Combination

Drug

subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.

Other names: ATNC05

Placebo

Drug

subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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).

  2. 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

    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).

  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

    A self-reported scale that measures Treatment Satisfaction today in (0-10, 0 - none, 10 - most satisfied)

  4. 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

    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)

  5. 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

    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.

  6. 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

    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).

  7. 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

  8. 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

  9. 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

    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.

  10. 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

    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.

  11. 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

    Answer, yes/no and by 0%-100% (0%-not at all better, 100% - very much better off

  12. 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

    The subjects answer, one of the following choices, - 150%, -100%, -50%, - 25%, 0% - same activity level, +25%, +50%, +100%, +150%

  13. 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 answer yes/no.

  14. Subject's Global Assessment of Disease Activity Improved / No Change

    Time frame: baseline to week 1, week 2 and week 3

    The Subject answer either Improved or No Change.

  15. Subject's Global Evaluation of Study Medication.

    Time frame: baseline to week 1, week 2 and week 3

    The subject chooses, 1 - Excellent, 2 - Very Good, 3 - Good, 4 - Fair, 5 - Poor

  16. The Subject's Satisfaction with Pain Relief, 0 - 10.

    Time frame: baseline to week 1, week 2 and week 3

    The subject answers on a scale of 0-10, (0 - not satisfied, 10 - very satisfied).

  17. 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.

    The subjects answers on a scale of 0-10, (0 - not satisfied, 10 - very satisfied)

  18. 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

    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).

Sponsors and collaborators

Lead sponsor

Annette C. Toledano MD

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 12, 2011
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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