Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01562548
• Collaborator: (none)
• Enrollment: 78
• Locations: 5
• Arms: 4
• Duration (Months): 14.9
• Patients Per Site: 15.6
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Back Pain	Drug: Guaifenesin; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Proof of Principle Study to Explore the Utility of Guaifenesin in Upper Back Pain
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Guaifenesin 1 tablet BID	Drug: Guaifenesin; high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
Experimental: Arm 2 Guaifenesin 2 tablets BID	Drug: Guaifenesin; high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
Placebo Comparator: Arm 3 Placebo 1 tablet BID	Drug: Placebo; no active ingredient
Placebo Comparator: Arm 4 Placebo 2 tablets BID	Drug: Placebo; no active ingredient

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline of Both AM and PM Spasm Assessment Scores [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.

Secondary Outcome Measures

1. Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores [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.

2. Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores [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.

3. Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores [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.

4. Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores [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.

5. Muscle Relaxation Scores [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.

6. Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores [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.

7. Global Assessment of Treatment Helpfulness (GATH) [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.

8. Global Assessment of Sleep Disturbance (GASD) [7 Days]

   Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.

9. Global Assessment of Headache Frequency (GAHF) [7 Days]

   Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.

10. Global Assessment of Headache Intensity (GAHI) [7 Days]

    Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Med Investigations	Fair Oaks	California	United States	95628
2	San Diego Sports Medicine and Family Health Center	San Diego	California	United States	92120
3	Radiant Research - Cincinnati	Cincinnati	Ohio	United States	45249
4	Radiant Research, Inc. - TX	San Antonio	Texas	United States	78229
5	J. Lewis Research	Salt Lake City	Utah	United States	84109

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01562548
• Other Study ID Numbers: A3940666
• First Posted: Mar 26, 2012
• Last Update Posted: Jun 3, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by GlaxoSmithKline: upper back/neck/shoulder muscle spasm
• Additional relevant MeSH terms: Back Pain; Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination

Study Results

Participant Flow

Recruitment Details	Participants were recruited at multiple clinical sites
Pre-assignment Detail	Male or female participants aged 18-65 years (inclusive) with acute onset upper back/neck/shoulder muscle spasm and pain were recruited in this study

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Period Title: Overall Study
STARTED	25	15	25	14
COMPLETED	25	15	24	14
NOT COMPLETED	0	0	1	0

Baseline Characteristics

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg	Total
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Total of all reporting groups
Overall Participants	25	15	24	14	78
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	47.2 (11.87)	43.8 (10.35)	45.3 (10.62)	47.3 (13.92)	45.9 (11.47)
Sex: Female, Male (Count of Participants)
Female	8 32%	9 60%	12 50%	6 42.9%	35 44.9%
Male	17 68%	6 40%	12 50%	8 57.1%	43 55.1%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline of Both AM and PM Spasm Assessment Scores
Description	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.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis was conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. Subjects were analyzed according to the treatment to which they were randomized.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID for 7 consecutive days
Measure Participants	25	15	24	13
Mean (Standard Deviation) [Score on a Scale]	1.66 (1.806)	1.87 (1.644)	1.91 (1.541)	1.54 (1.203)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Guaifenesin 600mg, Placebo Matching Guaifenesin 600mg
	Comments	Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments	P-value was associated with t-test for difference of LS means
	Method	t-test, 2 sided
	Comments	The model included factors for treatment (as a fixed effect) and site (as a random effect).
Method of Estimation	Estimation Parameter	Least Squares Means Difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -1.23 to 0.80
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Guaifenesin 1200mg, Placebo Matching Guaifenesin 1200mg
	Comments	Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments	P-value associated with t-test for difference of LS means
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Least Squares Means Difference
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 95%; -0.72 to 1.42
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Guaifenesin 600mg, Guaifenesin 1200mg
	Comments	Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments	P-value associated with t-test for difference of LS means
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Least Squares Means Difference
	Estimated Value	0.24
	Confidence Interval	(2-Sided) 95%; -0.64 to 1.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was Second named treatment - first named treatment

2. Secondary Outcome

Title	Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores
Description	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.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who receive at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Mean (Standard Deviation) [Score on a scale]	1.90 (1.684)	2.09 (1.225)	1.87 (1.630)	1.77 (1.214)

3. Secondary Outcome

Title	Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores
Description	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.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Mean (Standard Deviation) [Score on a scale]	1.74 (1.721)	1.98 (1.496)	1.97 (1.540)	1.54 (1.678)

4. Secondary Outcome

Title	Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores
Description	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.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Mean (Standard Deviation) [Score on a scale]	1.65 (2.028)	2.41 (1.376)	2.14 (1.539)	1.41 (0.995)

5. Secondary Outcome

Title	Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores
Description	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.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Mean (Standard Deviation) [Score on a scale]	1.95 (1.824)	2.57 (1.406)	2.33 (1.668)	1.12 (1.459)

6. Secondary Outcome

Title	Muscle Relaxation Scores
Description	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.
Time Frame	4 Days, 7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Degree of Muscle Relaxation at Day 4	1.80 (0.829)	1.90 (0.507)	1.85 (0.759)	1.35 (0.826)
Degree of Muscle Relaxation at Day 7	1.86 (0.860)	2.27 (0.980)	2.17 (1.007)	1.69 (1.146)

7. Secondary Outcome

Title	Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores
Description	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.
Time Frame	Before treatment, 4 Days, 7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Pain Intensity-before treatment	3.88 (0.781)	3.67 (0.816)	3.25 (0.897)	3.62 (0.650)
Pain Intensity-Day 4	2.72 (0.980)	2.53 (0.834)	2.29 (0.955)	2.83 (0.577)
Pain Intensity-Day 7	2.48 (0.918)	2.20 (0.862)	1.88 (0.797)	1.92 (0.641)
Personal Care-before treatment	1.96 (0.735)	2.07 (0.799)	2.00 (0.780)	2.00 (0.816)
Personal Care-Day 4	1.72 (0.678)	1.60 (0.632)	1.50 (0.511)	1.75 (0.754)
Personal Care-Day 7	1.60 (0.707)	1.33 (0.488)	1.29 (0.550)	1.46 (0.519)
Lifting-before treatment	3.04 (1.060)	3.13 (1.302)	2.92 (1.139)	3.15 (1.144)
Lifting-Day 4	2.80 (1.258)	2.27 (1.100)	2.58 (1.139)	2.42 (1.311)
Lifting-Day 7	2.56 (1.387)	2.00 (1.309)	2.04 (0.999)	2.00 (1.291)
Reading-before treatment	3.00 (1.225)	2.67 (0.976)	2.29 (1.042)	2.92 (1.038)
Reading-Day 4	2.40 (0.913)	2.20 (1.014)	1.88 (0.947)	2.38 (0.650)
Reading-Day 7	2.00 (0.707)	1.73 (0.799)	1.58 (0.776)	1.85 (0.689)
Headache-before treatment	1.72 (0.980)	1.87 (0.743)	1.79 (0.932)	2.23 (0.832)
Headache-Day 4	1.76 (1.165)	1.67 (0.900)	2.04 (1.367)	2.23 (0.832)
Headache-Day 7	1.60 (0.913)	1.67 (0.617)	1.75 (1.152)	2.00 (0.816)
Concentration-before treatment	2.12 (1.013)	2.20 (1.320)	1.88 (0.992)	2.08 (0.494)
Concentration-Day 4	1.75 (0.737)	1.60 (0.507)	1.54 (0.588)	2.00 (0.707)
Concentration-Day 7	1.76 (0.831)	1.53 (0.640)	1.46 (0.588)	1.62 (0.506)
Work-before treatment	2.64 (1.186)	2.80 (1.014)	2.50 (0.834)	3.00 (1.354)
Work-Day 4	2.20 (0.957)	2.13 (0.915)	1.92 (0.929)	2.46 (0.877)
Work-Day 7	1.96 (0.841)	1.73 (0.799)	1.75 (0.847)	2.08 (1.382)
Driving-before treatment	3.12 (1.424)	2.67 (0.816)	2.21 (0.779)	3.00 (1.225)
Driving-Day 4	2.56 (1.530)	2.13 (1.302)	1.79 (0.779)	2.38 (1.193)
Driving-Day 7	2.48 (1.503)	2.00 (1.254)	1.46 (0.509)	2.15 (1.345)
Sleeping-before treatment	3.16 (1.179)	3.47 (1.356)	2.96 (1.083)	3.23 (1.363)
Sleeping-Day 4	2.76 (1.363)	2.67 (1.291)	2.42 (1.139)	2.92 (1.188)
Sleeping-Day 7	2.56 (1.193)	2.20 (0.862)	2.04 (1.083)	1.92 (0.954)
Recreation-before treatment	3.44 (1.261)	3.27 (1.100)	2.88 (0.992)	3.23 (1.235)
Recreation-Day 4	2.44 (1.121)	2.40 (1.121)	2.17 (0.917)	2.54 (1.266)
Recreation-Day 7	2.29 (1.083)	1.73 (0.594)	1.88 (1.035)	2.08 (1.320)

8. Secondary Outcome

Title	Global Assessment of Treatment Helpfulness (GATH)
Description	Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent.
Time Frame	4 Days, 7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Global Assessment of Treatment Helpfulness- Day 4	1.48 (1.194)	1.53 (0.743)	1.63 (0.824)	0.85 (0.899)
Global Assessment of Treatment Helpfulness- Day 7	1.56 (1.083)	1.73 (1.163)	1.71 (0.999)	1.38 (1.121)

9. Secondary Outcome

Title	Global Assessment of Sleep Disturbance (GASD)
Description	Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Global Assessment of Sleep Disturbance-Decreased	8 32%	8 53.3%	10 41.7%	7 50%
Global Assessment of Sleep Disturbance-Increased	1 4%	0 0%	2 8.3%	1 7.1%
Global Assessment of Sleep Disturbance-Stayed same	16 64%	7 46.7%	12 50%	5 35.7%

10. Secondary Outcome

Title	Global Assessment of Headache Frequency (GAHF)
Description	Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Headache frequency-decreased	9 36%	9 60%	7 29.2%	4 28.6%
Headache frequency-increased	3 12%	0 0%	1 4.2%	0 0%
Headache frequency-stayed same	13 52%	6 40%	16 66.7%	9 64.3%

11. Secondary Outcome

Title	Global Assessment of Headache Intensity (GAHI)
Description	Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time Frame	7 Days

Outcome Measure Data

Analysis Population Description

Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.

Arm/Group Title	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Measure Participants	25	15	24	13
Headache Intensity-decreased	10 40%	9 60%	9 37.5%	4 28.6%
Headache Intensity-increased	1 4%	0 0%	1 4.2%	0 0%
Headache Intensity-stayed same	14 56%	6 40%	14 58.3%	9 64.3%

Adverse Events

Time Frame	All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Arm/Group Title	Guaifenesin 600mg		Placebo Matching Guaifenesin 600mg		Guaifenesin 1200mg		Placebo Matching Guaifenesin 1200mg
Arm/Group Description	Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days		1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days		2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days		2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
All Cause Mortality
	Guaifenesin 600mg		Placebo Matching Guaifenesin 600mg		Guaifenesin 1200mg		Placebo Matching Guaifenesin 1200mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Guaifenesin 600mg		Placebo Matching Guaifenesin 600mg		Guaifenesin 1200mg		Placebo Matching Guaifenesin 1200mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/15 (0%)		0/24 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Guaifenesin 600mg		Placebo Matching Guaifenesin 600mg		Guaifenesin 1200mg		Placebo Matching Guaifenesin 1200mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/25 (28%)		1/15 (6.7%)		6/24 (25%)		3/14 (21.4%)
Gastrointestinal disorders
Abdominal Discomfort	0/25 (0%)	0	1/15 (6.7%)	1	0/24 (0%)	0	0/14 (0%)	0
General disorders
Fatigue	1/25 (4%)	1	0/15 (0%)	0	1/24 (4.2%)	1	0/14 (0%)	0
Infections and infestations
Sinusitis	0/25 (0%)	0	0/15 (0%)	0	0/24 (0%)	0	1/14 (7.1%)	1
Upper Respiratory Tract Infection	1/25 (4%)	1	0/15 (0%)	0	1/24 (4.2%)	1	0/14 (0%)	0
Nasopharyngitis	0/25 (0%)	0	0/15 (0%)	0	1/24 (4.2%)	1	0/14 (0%)	0
Viral Upper Respiratory Tract Infection	0/25 (0%)	0	0/15 (0%)	0	1/24 (4.2%)	1	0/14 (0%)	0
Musculoskeletal and connective tissue disorders
Anthralgia	1/25 (4%)	1	0/15 (0%)	0	0/24 (0%)	0	0/14 (0%)	0
Nervous system disorders
Headache	1/25 (4%)	1	0/15 (0%)	0	1/24 (4.2%)	1	2/14 (14.3%)	2
Dizziness	1/25 (4%)	1	0/15 (0%)	0	1/24 (4.2%)	1	2/14 (14.3%)	2
Dysgeusia	1/25 (4%)	1	0/15 (0%)	0	0/24 (0%)	0	0/14 (0%)	0
Somnolence	1/25 (4%)	1	0/15 (0%)	0	0/24 (0%)	0	0/14 (0%)	0
Psychiatric disorders
Sleep Disorder	0/25 (0%)	0	0/15 (0%)	0	0/24 (0%)	0	1/14 (7.1%)	1
Respiratory, thoracic and mediastinal disorders
Epistaxis	0/25 (0%)	0	0/15 (0%)	0	1/24 (4.2%)	1	0/14 (0%)	0
Skin and subcutaneous tissue disorders
Hyperhidrosis	0/25 (0%)	0	0/15 (0%)	0	1/24 (4.2%)	1	0/14 (0%)	0
Surgical and medical procedures
Sinus Operation	1/25 (4%)	1	0/15 (0%)	0	0/24 (0%)	0	0/14 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.