Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

NCT01562548 | Completed Results

• 1 other identifier: A3940666
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 5

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.

Conditions

Upper Back Pain

Keywords

upper back/neck/shoulder muscle spasm

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline of Both AM and PM Spasm Assessment Scores

  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.

  7 Days

Secondary Outcomes (10)

• Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores

  7 Days

• Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores

  7 Days

• Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores

  7 Days

• Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores

  7 Days

• Muscle Relaxation Scores

  4 Days, 7 Days

Study Arms (4)

Arm 1

EXPERIMENTAL

Guaifenesin 1 tablet BID

Drug: Guaifenesin

Arm 2

EXPERIMENTAL

Guaifenesin 2 tablets BID

Drug: Guaifenesin

Arm 3

PLACEBO COMPARATOR

Placebo 1 tablet BID

Drug: Placebo

Arm 4

PLACEBO COMPARATOR

Placebo 2 tablets BID

Drug: Placebo

Interventions

Guaifenesin DRUG

high and low dose of Guaifenesin each given twice daily over a 4-day treatment period

Arm 1; Arm 2

Placebo DRUG

no active ingredient

Arm 3; Arm 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that:
• is at least 30 days from previous episode.
• has an onset occurred within 48 hours of Visit 1.
• has symptoms consistent with a clinical diagnosis as per the physical examination at Visit 1.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

Med Investigations

Fair Oaks, California, 95628, United States

Location

San Diego Sports Medicine and Family Health Center

San Diego, California, 92120, United States

Location

Radiant Research - Cincinnati

Cincinnati, Ohio, 45249, United States

Location

Radiant Research, Inc. - TX

San Antonio, Texas, 78229, United States

Location

J. Lewis Research

Salt Lake City, Utah, 84109, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Guaifenesin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guaiacol; Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 3, 2014
• Results First Posted: June 3, 2014

Record last verified: 2014-03

Locations

US (5)