Clinical trial NCT01415895: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Back Pain
Lower Back Pain
Cervical Pain
Keywords: back pain
cervical pain
neuropathic pain
radicular pain
Lead sponsor: Allodynic Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for average pain (Question #5)
timeFrame: baseline to week 3
Secondary outcomes:
measure: Change from Baseline in Brief Pain Inventory 24-hour assessment of interference in function (Questions 9a - 9i).
timeFrame: baseline to week 1, week 2 and week 3
measure: Change From Baseline in Brief Pain Inventory 24-hour subject's Global Impression of Improvement (Question 8)
timeFrame: baseline to week 1, week 2 and week 3
measure: Change From Baseline in the subject's Global Assessment of Treatment Satisfaction today
timeFrame: baseline to week 1, week 2 and week 3
measure: Change from Baseline in the subject's perception of Ability to Tolerate the study drug and the severity of side effects today.
timeFrame: baseline to week 1, week 2 and week 3
measure: Change From Baseline in Oswestry Disability Index and Neck Disability composite scores(ODI), to Week 1, Week 2, and Week 3
timeFrame: baseline to week 1, week 2 and week 3
measure: Change From Baseline in Roland Morris Disability Questionnaire composite scores(ODI), to Week 1, Week 2, and Week 3
timeFrame: baseline to week 1, week 2 and week 3
measure: 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.
timeFrame: baseline to week 1, week 2 and week 3
measure: 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
timeFrame: baseline to week 1, week 2 and week 3
measure: Change from Baseline in the investigator's Clinical Global Impression - Severity scale (CGI-S) to Week 1, Week 2, week 3 .
timeFrame: baseline to week 1, week 2 and week 3
measure: Change from Baseline in The investigator's Clinical Global Impression - Improvement scale (CGI-I) to Week 1, Week 2, week 3
timeFrame: baseline to week 1, week 2 and week 3
measure: 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?
timeFrame: baseline to week 1, week 2 and week 3
measure: 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 %.
timeFrame: baseline to week 1, week 2 and week 3
measure: Subject's response to the question, "Have you responded to the treatment?"
timeFrame: baseline to week 1, week 2 and week 3
measure: Subject's Global Assessment of Disease Activity Improved / No Change
timeFrame: baseline to week 1, week 2 and week 3
measure: Subject's Global Evaluation of Study Medication.
timeFrame: baseline to week 1, week 2 and week 3
measure: The Subject's Satisfaction with Pain Relief, 0 - 10.
timeFrame: baseline to week 1, week 2 and week 3
measure: The Subject's Satisfaction with Moving, Standing, Walking and Bending Ability Scale, 0-10.
timeFrame: baseline to week 1, week 2 and week 3.
measure: 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)
timeFrame: baseline to week 1, week 2 and week 3
Other outcomes:
Locations:
city: North Miami
country: United States
facility: Annette C. Toledano MD
state: Florida
Study officials:
affiliation: Allodynic Therapeutics, Inc
name: Annette C Toledano, MD
role: PRINCIPAL_INVESTIGATOR
References: