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Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to investigate the evidence that guaifenesin is an effective treatment for upper back/neck/shoulder muscle spasm/stiffness and pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Guaifenesin 1 tablet BID |
|
| Arm 2 | Experimental | Guaifenesin 2 tablets BID |
|
| Arm 3 | Placebo Comparator | Placebo 1 tablet BID |
|
| Arm 4 | Placebo Comparator | Placebo 2 tablets BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guaifenesin | Drug | high and low dose of Guaifenesin each given twice daily over a 4-day treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness. | 7 Days |
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Inclusion Criteria:
Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that:
Paticipant has a normal neurological examination.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Med Investigations | Fair Oaks | California | 95628 | United States | ||
| San Diego Sports Medicine and Family Health Center |
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
Participants were recruited at multiple clinical sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Guaifenesin 600mg | Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days |
| FG001 | Placebo Matching Guaifenesin 600mg | 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days |
| FG002 | Guaifenesin 1200mg | 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days |
| FG003 | Placebo Matching Guaifenesin 1200mg | 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Guaifenesin 600mg | Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days |
| BG001 | Placebo Matching Guaifenesin 600mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm. | 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. | Posted | Mean | Standard Deviation | Score on a Scale | 7 Days |
|
All adverse events were collected from the start of the investigational product, and until 7 days following last administration of the investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guaifenesin 600mg | Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006140 | Guaifenesin |
| ID | Term |
|---|---|
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010647 |
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| Placebo | Drug | no active ingredient |
|
| Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension. | 7 Days |
| Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain. | 7 Days |
| Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort. | 7 Days |
| Muscle Relaxation Scores | 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. | 4 Days, 7 Days |
| Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | 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. | Before treatment, 4 Days, 7 Days |
| Global Assessment of Treatment Helpfulness (GATH) | Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent. | 4 Days, 7 Days |
| Global Assessment of Sleep Disturbance (GASD) | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. | 7 Days |
| Global Assessment of Headache Frequency (GAHF) | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. | 7 Days |
| Global Assessment of Headache Intensity (GAHI) | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. | 7 Days |
| San Diego |
| California |
| 92120 |
| United States |
| Radiant Research - Cincinnati | Cincinnati | Ohio | 45249 | United States |
| Radiant Research, Inc. - TX | San Antonio | Texas | 78229 | United States |
| J. Lewis Research | Salt Lake City | Utah | 84109 | United States |
1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
| BG002 | Guaifenesin 1200mg | 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days |
| BG003 | Placebo Matching Guaifenesin 1200mg | 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo Matching Guaifenesin 600mg | 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID for 7 consecutive days |
| OG002 | Guaifenesin 1200mg | 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days |
| OG003 | Placebo Matching Guaifenesin 1200mg | 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID for 7 consecutive days |
|
|
|
| Secondary | Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 7 Days |
|
|
|
| Secondary | Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 7 Days |
|
|
|
| Secondary | Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 7 Days |
|
|
|
| Secondary | Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 7 Days |
|
|
|
| Secondary | Muscle Relaxation Scores | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 4 Days, 7 Days |
|
|
|
| Secondary | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Before treatment, 4 Days, 7 Days |
|
|
|
| Secondary | Global Assessment of Treatment Helpfulness (GATH) | Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 4 Days, 7 Days |
|
|
|
| Secondary | Global Assessment of Sleep Disturbance (GASD) | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. | 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. | Posted | Number | participants | 7 Days |
|
|
|
| Secondary | Global Assessment of Headache Frequency (GAHF) | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. | 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. | Posted | Number | participants | 7 Days |
|
|
|
| Secondary | Global Assessment of Headache Intensity (GAHI) | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. | 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. | Posted | Number | participants | 7 Days |
|
|
|
| 0 |
| 25 |
| 7 |
| 25 |
| EG001 | Placebo Matching Guaifenesin 600mg | 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days | 0 | 15 | 1 | 15 |
| EG002 | Guaifenesin 1200mg | 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days | 0 | 24 | 6 | 24 |
| EG003 | Placebo Matching Guaifenesin 1200mg | 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days | 0 | 14 | 3 | 14 |
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Viral Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Anthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sinus Operation | Surgical and medical procedures | Systematic Assessment |
|
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.
| Phenyl Ethers |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Degree of Muscle Relaxation at Day 7 |
|
| Pain Intensity-Day 4 |
|
| Pain Intensity-Day 7 |
|
| Personal Care-before treatment |
|
| Personal Care-Day 4 |
|
| Personal Care-Day 7 |
|
| Lifting-before treatment |
|
| Lifting-Day 4 |
|
| Lifting-Day 7 |
|
| Reading-before treatment |
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| Reading-Day 4 |
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| Reading-Day 7 |
|
| Headache-before treatment |
|
| Headache-Day 4 |
|
| Headache-Day 7 |
|
| Concentration-before treatment |
|
| Concentration-Day 4 |
|
| Concentration-Day 7 |
|
| Work-before treatment |
|
| Work-Day 4 |
|
| Work-Day 7 |
|
| Driving-before treatment |
|
| Driving-Day 4 |
|
| Driving-Day 7 |
|
| Sleeping-before treatment |
|
| Sleeping-Day 4 |
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| Sleeping-Day 7 |
|
| Recreation-before treatment |
|
| Recreation-Day 4 |
|
| Recreation-Day 7 |
|
| Global Assessment of Treatment Helpfulness- Day 7 |
|
| Global Assessment of Sleep Disturbance-Increased |
|
| Global Assessment of Sleep Disturbance-Stayed same |
|
| Headache frequency-increased |
|
| Headache frequency-stayed same |
|
| Headache Intensity-increased |
|
| Headache Intensity-stayed same |
|