Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Upper Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

Guaifenesin 1 tablet BID

Group Type EXPERIMENTAL

Guaifenesin

Intervention Type DRUG

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

Arm 2

Guaifenesin 2 tablets BID

Group Type EXPERIMENTAL

Guaifenesin

Intervention Type DRUG

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

Arm 3

Placebo 1 tablet BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

no active ingredient

Arm 4

Placebo 2 tablets BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

no active ingredient

Interventions

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Guaifenesin

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

Intervention Type DRUG

Placebo

no active ingredient

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No