Efficacy of ATNC05 in Reducing Back Pain Compared With Placebo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Annette C. Toledano MD, Allodynic Therapeutics, LLC
ClinicalTrials.gov Identifier:
NCT01415895
First received: August 11, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

ATNC05 is a combination of two known marketed generic compounds. The investigators hypothesize that the combination acts synergistically to reduce chronic radicular neuropathic back pain of the cervical, thoracic and the lumbar regions.


Condition Intervention Phase
Back Pain
Lower Back Pain
Cervical Pain
Drug: ATNC05 - a study drug capsule
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: ATNC05, A Composition to Reduce Back Pain, A Proof-of-Concept, Randomized, Double-Blind - Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Allodynic Therapeutics, LLC:

Primary Outcome Measures:
  • Change from Baseline in Brief Pain Inventory 24-hour Pain Scores for average pain (Question #5) [ Time Frame: baseline to week 3 ] [ Designated as safety issue: No ]
    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). [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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? [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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 %. [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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?" [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    Subject's answer yes/no.

  • Subject's Global Assessment of Disease Activity Improved / No Change [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    The Subject answer either Improved or No Change.

  • Subject's Global Evaluation of Study Medication. [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    The subject chooses, 1 - Excellent, 2 - Very Good, 3 - Good, 4 - Fair, 5 - Poor

  • The Subject's Satisfaction with Pain Relief, 0 - 10. [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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. [ Time Frame: baseline to week 1, week 2 and week 3. ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline to week 1, week 2 and week 3 ] [ Designated as safety issue: No ]
    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).


Enrollment: 78
Study Start Date: July 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATNC05 - a study drug capsule
ATNC05, a capsule containing a weighed piece of generic tablet A and a weighed piece of generic tablet B
Drug: ATNC05 - a study drug capsule
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 Name: ATNC05 - the study drug capsules.
Placebo Comparator: placebo
subjects will receive placebo capsules for double blind treatment for the duration of the trial
Drug: 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 Name: placebo

Detailed Description:

Back pain represents one of the most common and chronic physical ailments. In the United States, acute back pain is the fifth most common reason for physician visits. In fact, nine of ten adults experience back pain at some point in their life, and five out of ten working adults report back pain every year.

While only a minority of individuals suffering from back pain resort to surgery, there are only limited options for offering relief from chronic back pain. Heat therapy is one option for short term relief, as well as alternative cold compression therapy proximate to the location of pain. Alternative treatments such as massage therapy, acupressure and pressure point massage have also been used. Some pharmaceuticals have shown usefulness in treating back pain, including muscle relaxants, non-steroidal anti-inflammatory drugs, analgesics and Opioid Agonists. However opioids are limited by side effects such as constipation and sedation, as well as by dependence, tolerance and scheduling issue. NSAIDs avoid some of the liabilities of opioids, yet they also have toxicities which can limit their usefulness.

Accordingly, there is a need in the art of treating back pain for an alternative pharmaceutical composition that reduces the symptoms of back pain effectively and for longer periods of time.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415895

Locations
United States, Florida
Annette C. Toledano MD
North Miami, Florida, United States, 33181
Sponsors and Collaborators
Annette C. Toledano MD
Investigators
Principal Investigator: Annette C Toledano, MD Allodynic Therapeutics, LLC
  More Information

No publications provided

Responsible Party: Annette C. Toledano MD, Sponsor/Investigator, Allodynic Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT01415895     History of Changes
Other Study ID Numbers: AT110491
Study First Received: August 11, 2011
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Allodynic Therapeutics, LLC:
back pain
cervical pain
neuropathic pain
radicular pain

Additional relevant MeSH terms:
Back Pain
Neck Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014