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Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01562548
First received: March 22, 2012
Last updated: May 1, 2014
Last verified: March 2014
  Purpose

Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to investigate the evidence that guaifenesin is an effective treatment for upper back/neck/shoulder muscle spasm/stiffness and pain.


Condition Intervention
Upper Back Pain
Drug: Guaifenesin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline of Both AM and PM Spasm Assessment Scores [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm.


Secondary Outcome Measures:
  • Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness.

  • Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension.

  • Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain.

  • Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort.

  • Muscle Relaxation Scores [ Time Frame: 4 Days, 7 Days ] [ Designated as safety issue: No ]
    The score was measured as mean of both AM and PM assessment scores at Days 4 and 7. Measurements were based on a 5 categorical scale: 0 - no relaxation, 1- a little relaxation, 2 - fair relaxation, 3 - good relaxation, 4 - complete muscle relaxation.

  • Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores [ Time Frame: Before treatment, 4 Days, 7 Days ] [ Designated as safety issue: No ]
    Vernon-Mior upper back/neck/shoulder components were assessed before the treatment and at Days 4 and 7. Each component (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) was assessed based on a 6-point categorical scale (1 to 6), with 1 being the most positive and 6 being the worst.

  • Global Assessment of Treatment Helpfulness (GATH) [ Time Frame: 4 Days, 7 Days ] [ Designated as safety issue: No ]
    Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent.

  • Global Assessment of Sleep Disturbance (GASD) [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.

  • Global Assessment of Headache Frequency (GAHF) [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.

  • Global Assessment of Headache Intensity (GAHI) [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
    Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.


Enrollment: 78
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Guaifenesin 1 tablet BID
Drug: Guaifenesin
high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
Experimental: Arm 2
Guaifenesin 2 tablets BID
Drug: Guaifenesin
high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
Placebo Comparator: Arm 3
Placebo 1 tablet BID
Drug: Placebo
no active ingredient
Placebo Comparator: Arm 4
Placebo 2 tablets BID
Drug: Placebo
no active ingredient

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that:

    1. is at least 30 days from previous episode.
    2. has an onset occurred within 48 hours of Visit 1.
    3. has symptoms consistent with a clinical diagnosis as per the physical examination at Visit 1.
    4. has a subject-rated muscle spasm score and a pain score of at least 40 out of 100 on a 100mm VAS.
  • Paticipant has a normal neurological examination.

Exclusion Criteria:

  • Medical history: a) Paticipant has a known or suspected intolerance or hypersensitivity to guaifenesin or methocarbamol (or closely related compounds) or any of their stated ingredients. b) Paticipant has history of upper back pain with active hypersensitive spots - trigger point in the muscles of upper back/neck/shoulder/maxillofacial regions. c) Paticipant has a current or recent history of liver and/or kidney disease, neck/back/shoulder injuries, spinal disc disease, myocardial infarction (<12 months from Visit 1) and osteoporosis. d) Subjects have history of other chronic pain e.g. headache, osteoarthritis, arthritis, lower back pain etc.
  • Medications: a) Paticipant has used a muscle relaxant or narcotic within 2 weeks of Visit 1. b) Paticipant has used monoamine oxidase inhibitors or selegiline within 2 weeks of Visit 1 c) Currently using tricyclic antidepressants, lithium, anticoagulants, or tramadol.
  • Paticipant is involved in a workers compensation case.
  • Paticipant is unlikely to refrain from using analgesics, NSAIDs, and other muscle relaxants for the duration of the study, with the exception of cardioprotective doses of aspirin (i.e., ≤ 325 mg/day).
  • Paticipant is unlikely to refrain from physical therapy, massage therapy, acupuncture, heat treatment, spas, etc for the duration of the study.
  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: NCT01562548

Locations
United States, California
Med Investigations
Fair Oaks, California, United States, 95628
San Diego Sports Medicine and Family Health Center
San Diego, California, United States, 92120
United States, Ohio
Radiant Research - Cincinnati
Cincinnati, Ohio, United States, 45249
United States, Texas
Radiant Research, Inc. - TX
San Antonio, Texas, United States, 78229
United States, Utah
J. Lewis Research
Salt Lake City, Utah, United States, 84109
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01562548     History of Changes
Other Study ID Numbers: A3940666
Study First Received: March 22, 2012
Results First Received: March 6, 2014
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
upper back/neck/shoulder muscle spasm

Additional relevant MeSH terms:
Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Chlorpheniramine, phenylpropanolamine drug combination
Guaifenesin
Phenylpropanolamine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Anti-Obesity Agents
Appetite Depressants
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Expectorants
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 24, 2014