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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

March 22, 2012
May 1, 2014
February 2012
May 2013   (final data collection date for primary outcome measure)
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.
  • Global Assessment [ Time Frame: Day 4, Day 7 ] [ Designated as safety issue: No ]
    Global Upper Back/Neck/Shoulder Assessment
  • Vernon-Mior Disability Questionnaire [ Time Frame: Day 1 (Screening), Day 4, Day 7 ] [ Designated as safety issue: No ]
    Neck Pain & Disability
  • Daily Upper Back/Neck/Shoulder Symptom Assessment [ Time Frame: Day 2, Day 4, Day 7, Day 9 (follow-up) ] [ Designated as safety issue: No ]
    Diary Card
Complete list of historical versions of study NCT01562548 on ClinicalTrials.gov Archive Site
  • 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'.
AE Assessment [ Time Frame: Day 1 through Day 9 (follow-up) ] [ Designated as safety issue: Yes ]
frequency of adverse events (AEs) following treatment with the study medications.
Not Provided
Not Provided
 
Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Upper Back Pain
  • Drug: Guaifenesin
    high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
  • Drug: Placebo
    no active ingredient
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01562548
A3940666
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2014

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