Trial Outcomes & Findings for Exploratory Efficacy Study of Guaifenesin in Upper Back Pain (NCT NCT01562548)

Last Updated: 2014-06-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

78 participants

Primary outcome timeframe

7 Days

Results posted on

2014-06-03

Participant Flow

Participants were recruited at multiple clinical sites

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

Participant milestones

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

Reasons for withdrawal

Reasons for withdrawal
Measure	Guaifenesin 600mg Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 1200mg 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Overall Study Lost to Follow-up	0	0	1	0

Baseline Characteristics

Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=14 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Total n=78 Participants Total of all reporting groups
Age, Continuous	47.2 Years STANDARD_DEVIATION 11.87 • n=93 Participants	43.8 Years STANDARD_DEVIATION 10.35 • n=4 Participants	45.3 Years STANDARD_DEVIATION 10.62 • n=27 Participants	47.3 Years STANDARD_DEVIATION 13.92 • n=483 Participants	45.9 Years STANDARD_DEVIATION 11.47 • n=36 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	9 Participants n=4 Participants	12 Participants n=27 Participants	6 Participants n=483 Participants	35 Participants n=36 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants	8 Participants n=483 Participants	43 Participants n=36 Participants

PRIMARY outcome

Timeframe: 7 Days

Population: 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.

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Mean Change From Baseline of Both AM and PM Spasm Assessment Scores	1.91 Score on a Scale Standard Deviation 1.541	1.54 Score on a Scale Standard Deviation 1.203	1.66 Score on a Scale Standard Deviation 1.806	1.87 Score on a Scale Standard Deviation 1.644

SECONDARY outcome

Timeframe: 7 Days

Population: 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.

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores	1.87 Score on a scale Standard Deviation 1.630	1.77 Score on a scale Standard Deviation 1.214	1.90 Score on a scale Standard Deviation 1.684	2.09 Score on a scale Standard Deviation 1.225

SECONDARY outcome

Timeframe: 7 Days

Population: 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.

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores	1.97 Score on a scale Standard Deviation 1.540	1.54 Score on a scale Standard Deviation 1.678	1.74 Score on a scale Standard Deviation 1.721	1.98 Score on a scale Standard Deviation 1.496

SECONDARY outcome

Timeframe: 7 Days

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores	2.14 Score on a scale Standard Deviation 1.539	1.41 Score on a scale Standard Deviation 0.995	1.65 Score on a scale Standard Deviation 2.028	2.41 Score on a scale Standard Deviation 1.376

SECONDARY outcome

Timeframe: 7 Days

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores	2.33 Score on a scale Standard Deviation 1.668	1.12 Score on a scale Standard Deviation 1.459	1.95 Score on a scale Standard Deviation 1.824	2.57 Score on a scale Standard Deviation 1.406

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Muscle Relaxation Scores Degree of Muscle Relaxation at Day 4	1.85 Score on a scale Standard Deviation 0.759	1.35 Score on a scale Standard Deviation 0.826	1.80 Score on a scale Standard Deviation 0.829	1.90 Score on a scale Standard Deviation 0.507
Muscle Relaxation Scores Degree of Muscle Relaxation at Day 7	2.17 Score on a scale Standard Deviation 1.007	1.69 Score on a scale Standard Deviation 1.146	1.86 Score on a scale Standard Deviation 0.860	2.27 Score on a scale Standard Deviation 0.980

SECONDARY outcome

Timeframe: 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.

Outcome measures

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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Global Assessment of Treatment Helpfulness (GATH) Global Assessment of Treatment Helpfulness- Day 4	1.63 Score on a scale Standard Deviation 0.824	0.85 Score on a scale Standard Deviation 0.899	1.48 Score on a scale Standard Deviation 1.194	1.53 Score on a scale Standard Deviation 0.743
Global Assessment of Treatment Helpfulness (GATH) Global Assessment of Treatment Helpfulness- Day 7	1.71 Score on a scale Standard Deviation 0.999	1.38 Score on a scale Standard Deviation 1.121	1.56 Score on a scale Standard Deviation 1.083	1.73 Score on a scale Standard Deviation 1.163

SECONDARY outcome

Timeframe: 7 Days

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

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Global Assessment of Sleep Disturbance (GASD) Global Assessment of Sleep Disturbance-Stayed same	12 participants	5 participants	16 participants	7 participants
Global Assessment of Sleep Disturbance (GASD) Global Assessment of Sleep Disturbance-Decreased	10 participants	7 participants	8 participants	8 participants
Global Assessment of Sleep Disturbance (GASD) Global Assessment of Sleep Disturbance-Increased	2 participants	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 7 Days

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

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Global Assessment of Headache Frequency (GAHF) Headache frequency-decreased	7 participants	4 participants	9 participants	9 participants
Global Assessment of Headache Frequency (GAHF) Headache frequency-increased	1 participants	0 participants	3 participants	0 participants
Global Assessment of Headache Frequency (GAHF) Headache frequency-stayed same	16 participants	9 participants	13 participants	6 participants

SECONDARY outcome

Timeframe: 7 Days

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

Outcome measures

Outcome measures
Measure	Guaifenesin 1200mg n=24 Participants 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=13 Participants 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 600mg n=25 Participants Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 Participants 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
Global Assessment of Headache Intensity (GAHI) Headache Intensity-decreased	9 participants	4 participants	10 participants	9 participants
Global Assessment of Headache Intensity (GAHI) Headache Intensity-increased	1 participants	0 participants	1 participants	0 participants
Global Assessment of Headache Intensity (GAHI) Headache Intensity-stayed same	14 participants	9 participants	14 participants	6 participants

Adverse Events

Guaifenesin 600mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo Matching Guaifenesin 600mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Guaifenesin 1200mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo Matching Guaifenesin 1200mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Guaifenesin 600mg n=25 participants at risk Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days	Placebo Matching Guaifenesin 600mg n=15 participants at risk 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days	Guaifenesin 1200mg n=24 participants at risk 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days	Placebo Matching Guaifenesin 1200mg n=14 participants at risk 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
Nervous system disorders Headache	4.0% 1/25 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	4.2% 1/24 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	14.3% 2/14 • Number of events 2 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/25 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	6.7% 1/15 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/24 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Psychiatric disorders Sleep Disorder	0.00% 0/25 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/24 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	7.1% 1/14 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Infections and infestations Sinusitis	0.00% 0/25 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/24 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	7.1% 1/14 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	4.2% 1/24 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	14.3% 2/14 • Number of events 2 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Nervous system disorders Dysgeusia	4.0% 1/25 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/24 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Nervous system disorders Somnolence	4.0% 1/25 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/24 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Infections and infestations Upper Respiratory Tract Infection	4.0% 1/25 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	4.2% 1/24 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Infections and infestations Nasopharyngitis	0.00% 0/25 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	4.2% 1/24 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/25 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	4.2% 1/24 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
General disorders Fatigue	4.0% 1/25 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	4.2% 1/24 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Musculoskeletal and connective tissue disorders Anthralgia	4.0% 1/25 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/24 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/25 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	4.2% 1/24 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/25 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	4.2% 1/24 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
Surgical and medical procedures Sinus Operation	4.0% 1/25 • Number of events 1 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/15 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/24 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.	0.00% 0/14 • All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.