Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain
NCT ID: NCT01415895
Last Updated: 2021-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2011-07-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ATNC05 - a study drug capsule
Naltrexone and Clonidine Combination (ATNC05)
Naltrexone and Clonidine Combination
subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
placebo
placebo
subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
Interventions
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Naltrexone and Clonidine Combination
subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
placebo
subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
19 Years
70 Years
ALL
No
Sponsors
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Annette C. Toledano MD
INDUSTRY
Responsible Party
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Annette C. Toledano MD
Sponsor/Investigator
Principal Investigators
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Annette C Toledano, MD
Role: PRINCIPAL_INVESTIGATOR
Allodynic Therapeutics, Inc
Locations
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Annette C. Toledano MD
North Miami, Florida, United States
Countries
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Other Identifiers
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AT110491
Identifier Type: -
Identifier Source: org_study_id
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