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Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

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ClinicalTrials.gov Identifier: NCT01562548
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 26, 2012
Results First Submitted Date  ICMJE March 6, 2014
Results First Posted Date  ICMJE June 3, 2014
Last Update Posted Date June 3, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2014)
Mean Change From Baseline of Both AM and PM Spasm Assessment Scores [ Time Frame: 7 Days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • Vernon-Mior Disability Questionnaire [ Time Frame: Day 1 (Screening), Day 4, Day 7 ]
    Neck Pain & Disability
  • Daily Upper Back/Neck/Shoulder Symptom Assessment [ Time Frame: Day 2, Day 4, Day 7, Day 9 (follow-up) ]
    Diary Card
  • Global Assessment [ Time Frame: Day 4, Day 7 ]
    Global Upper Back/Neck/Shoulder Assessment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2014)
  • Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores [ Time Frame: 7 Days ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
  • Global Assessment of Headache Frequency (GAHF) [ Time Frame: 7 Days ]
    Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
  • Global Assessment of Headache Intensity (GAHI) [ Time Frame: 7 Days ]
    Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
AE Assessment [ Time Frame: Day 1 through Day 9 (follow-up) ]
frequency of adverse events (AEs) following treatment with the study medications.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
Official Title  ICMJE A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Upper Back Pain
Intervention  ICMJE
  • Drug: Guaifenesin
    high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
  • Drug: Placebo
    no active ingredient
Study Arms  ICMJE
  • Experimental: Arm 1
    Guaifenesin 1 tablet BID
    Intervention: Drug: Guaifenesin
  • Experimental: Arm 2
    Guaifenesin 2 tablets BID
    Intervention: Drug: Guaifenesin
  • Placebo Comparator: Arm 3
    Placebo 1 tablet BID
    Intervention: Drug: Placebo
  • Placebo Comparator: Arm 4
    Placebo 2 tablets BID
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2012)
78
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562548
Other Study ID Numbers  ICMJE A3940666
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP