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Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

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ClinicalTrials.gov Identifier: NCT01562548
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Upper Back Pain
Interventions Drug: Guaifenesin
Drug: Placebo
Enrollment 78
Recruitment Details Participants were recruited at multiple clinical sites
Pre-assignment Details 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
Hide 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
Reason Not Completed
Lost to Follow-up             0             0             1             0
Arm/Group Title Guaifenesin 600mg Placebo Matching Guaifenesin 600mg Guaifenesin 1200mg Placebo Matching Guaifenesin 1200mg Total
Hide 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 Number of Baseline Participants 25 15 24 14 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 15 participants 24 participants 14 participants 78 participants
47.2  (11.87) 43.8  (10.35) 45.3  (10.62) 47.3  (13.92) 45.9  (11.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 15 participants 24 participants 14 participants 78 participants
Female
8
  32.0%
9
  60.0%
12
  50.0%
6
  42.9%
35
  44.9%
Male
17
  68.0%
6
  40.0%
12
  50.0%
8
  57.1%
43
  55.1%
1.Primary Outcome
Title Mean Change From Baseline of Both AM and PM Spasm Assessment Scores
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
1.66  (1.806) 1.87  (1.644) 1.91  (1.541) 1.54  (1.203)
Hide 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 [Not Specified]
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
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
Hide 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 [Not Specified]
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 [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means Difference
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
-0.72 to 1.42
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
Hide 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 [Not Specified]
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 [Not Specified]
Method of Estimation Estimation Parameter Least Squares Means Difference
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.64 to 1.13
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Mean (Standard Deviation)
Unit of Measure: Score on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Mean (Standard Deviation)
Unit of Measure: Score on a scale
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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Mean (Standard Deviation)
Unit of Measure: Score on a scale
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)
Hide Description Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time Frame 7 Days
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Measure Type: Number
Unit of Measure: participants
Global Assessment of Sleep Disturbance-Decreased 8 8 10 7
Global Assessment of Sleep Disturbance-Increased 1 0 2 1
Global Assessment of Sleep Disturbance-Stayed same 16 7 12 5
10.Secondary Outcome
Title Global Assessment of Headache Frequency (GAHF)
Hide Description Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time Frame 7 Days
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Measure Type: Number
Unit of Measure: participants
Headache frequency-decreased 9 9 7 4
Headache frequency-increased 3 0 1 0
Headache frequency-stayed same 13 6 16 9
11.Secondary Outcome
Title Global Assessment of Headache Intensity (GAHI)
Hide Description Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time Frame 7 Days
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 15 24 13
Measure Type: Number
Unit of Measure: participants
Headache Intensity-decreased 10 9 9 4
Headache Intensity-increased 1 0 1 0
Headache Intensity-stayed same 14 6 14 9
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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Guaifenesin 600mg Placebo Matching Guaifenesin 600mg Guaifenesin 1200mg Placebo Matching Guaifenesin 1200mg
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide 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 (0.00%)      0/15 (0.00%)      0/24 (0.00%)      0/14 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
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 (28.00%)      1/15 (6.67%)      6/24 (25.00%)      3/14 (21.43%)    
Gastrointestinal disorders         
Abdominal Discomfort †  0/25 (0.00%)  0 1/15 (6.67%)  1 0/24 (0.00%)  0 0/14 (0.00%)  0
General disorders         
Fatigue †  1/25 (4.00%)  1 0/15 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0
Infections and infestations         
Sinusitis †  0/25 (0.00%)  0 0/15 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1
Upper Respiratory Tract Infection †  1/25 (4.00%)  1 0/15 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0
Nasopharyngitis †  0/25 (0.00%)  0 0/15 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0
Viral Upper Respiratory Tract Infection †  0/25 (0.00%)  0 0/15 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Anthralgia †  1/25 (4.00%)  1 0/15 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0
Nervous system disorders         
Headache †  1/25 (4.00%)  1 0/15 (0.00%)  0 1/24 (4.17%)  1 2/14 (14.29%)  2
Dizziness †  1/25 (4.00%)  1 0/15 (0.00%)  0 1/24 (4.17%)  1 2/14 (14.29%)  2
Dysgeusia †  1/25 (4.00%)  1 0/15 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0
Somnolence †  1/25 (4.00%)  1 0/15 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0
Psychiatric disorders         
Sleep Disorder †  0/25 (0.00%)  0 0/15 (0.00%)  0 0/24 (0.00%)  0 1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders         
Epistaxis †  0/25 (0.00%)  0 0/15 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders         
Hyperhidrosis †  0/25 (0.00%)  0 0/15 (0.00%)  0 1/24 (4.17%)  1 0/14 (0.00%)  0
Surgical and medical procedures         
Sinus Operation †  1/25 (4.00%)  1 0/15 (0.00%)  0 0/24 (0.00%)  0 0/14 (0.00%)  0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01562548    
Other Study ID Numbers: A3940666
First Submitted: March 22, 2012
First Posted: March 26, 2012
Results First Submitted: March 6, 2014
Results First Posted: June 3, 2014
Last Update Posted: June 3, 2014