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: July 11, 2013
Last verified: June 2013

March 22, 2012
July 11, 2013
February 2012
May 2013   (final data collection date for primary outcome measure)
  • 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
  • Global Assessment [ Time Frame: Day 4, Day 7 ] [ Designated as safety issue: No ]
    Global Upper Back/Neck/Shoulder Assessment
Same as current
Complete list of historical versions of study NCT01562548 on ClinicalTrials.gov Archive Site
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.
Same as current
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
June 2013

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