Trial · NCT01562548
Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
NCT01562548, Not applicable, Completed, GlaxoSmithKline; results first posted 2014-06-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Exploratory Efficacy Study of Guaifenesin in Upper Back Pain. Trials, record NCT01562548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01562548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Efficacy Study of Guaifenesin in Upper Back Pain
- NCT number
- NCT01562548
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 78 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Upper Back Pain
- Interventions
- Guaifenesin, Placebo
- First posted
- 2012-03-26
- Last updated
- 2014-06-03
- Results first posted
- 2014-06-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Global Assessment of Sleep Disturbance (GASD) | 7 Days | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. |
| Secondary | Global Assessment of Headache Frequency (GAHF) | 7 Days | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | 7 Days | 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. | Score on a Scale | MEAN |
| SECONDARY | Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | 7 Days | 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. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | 7 Days | 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. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores | 7 Days | 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. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores | 7 Days | 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. | Score on a scale | MEAN |
| SECONDARY | Muscle Relaxation Scores | 4 Days, 7 Days | 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. | Score on a scale | MEAN |
| SECONDARY | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Before treatment, 4 Days, 7 Days | 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. | Score on a scale | MEAN |
| SECONDARY | Global Assessment of Treatment Helpfulness (GATH) | 4 Days, 7 Days | 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. | Score on a scale | MEAN |
| SECONDARY | Global Assessment of Sleep Disturbance (GASD) | 7 Days | 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. | participants | NUMBER |
| SECONDARY | Global Assessment of Headache Frequency (GAHF) | 7 Days | 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. | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group192
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | Guaifenesin 600mg | 1.66 | Standard Deviation 1.806 | Score on a Scale | |
| Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | Placebo Matching Guaifenesin 600mg | 1.87 | Standard Deviation 1.644 | Score on a Scale | |
| Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | Guaifenesin 1200mg | 1.91 | Standard Deviation 1.541 | Score on a Scale | |
| Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | Placebo Matching Guaifenesin 1200mg | 1.54 | Standard Deviation 1.203 | Score on a Scale | |
| Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | Guaifenesin 600mg | 1.90 | Standard Deviation 1.684 | Score on a scale | |
| Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | Placebo Matching Guaifenesin 600mg | 2.09 | Standard Deviation 1.225 | Score on a scale | |
| Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | Guaifenesin 1200mg | 1.87 | Standard Deviation 1.630 | Score on a scale | |
| Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | Placebo Matching Guaifenesin 1200mg | 1.77 | Standard Deviation 1.214 | Score on a scale | |
| Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | Guaifenesin 600mg | 1.74 | Standard Deviation 1.721 | Score on a scale | |
| Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | Placebo Matching Guaifenesin 600mg | 1.98 | Standard Deviation 1.496 | Score on a scale |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Guaifenesin 600mg | 25 | |
| Overall Study | STARTED | Placebo Matching Guaifenesin 600mg | 15 | |
| Overall Study | STARTED | Guaifenesin 1200mg | 25 | |
| Overall Study | STARTED | Placebo Matching Guaifenesin 1200mg | 14 | |
| Overall Study | COMPLETED | Guaifenesin 600mg | 25 | |
| Overall Study | COMPLETED | Placebo Matching Guaifenesin 600mg | 15 | |
| Overall Study | COMPLETED | Guaifenesin 1200mg | 24 | |
| Overall Study | COMPLETED | Placebo Matching Guaifenesin 1200mg | 14 | |
| Overall Study | NOT COMPLETED | Guaifenesin 600mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo Matching Guaifenesin 600mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Guaifenesin 600mg | 1 | 25 | 1 |
| other | Headache | Nervous system disorders | Placebo Matching Guaifenesin 600mg | 0 | 15 | 0 |
| other | Headache | Nervous system disorders | Guaifenesin 1200mg | 1 | 24 | 1 |
| other | Headache | Nervous system disorders | Placebo Matching Guaifenesin 1200mg | 2 | 14 | 2 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Guaifenesin 600mg | 0 | 25 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo Matching Guaifenesin 600mg | 1 | 15 | 1 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Guaifenesin 1200mg | 0 | 24 | 0 |
| other | Abdominal Discomfort | Gastrointestinal disorders | Placebo Matching Guaifenesin 1200mg | 0 | 14 | 0 |
| other | Sleep Disorder | Psychiatric disorders | Guaifenesin 600mg | 0 | 25 | 0 |
| other | Sleep Disorder | Psychiatric disorders | Placebo Matching Guaifenesin 600mg | 0 | 15 | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Guaifenesin 600mg | ||
| Total, all-cause mortality | Placebo Matching Guaifenesin 600mg | ||
| Total, all-cause mortality | Guaifenesin 1200mg | ||
| Total, all-cause mortality | Placebo Matching Guaifenesin 1200mg | ||
| Total, other adverse events | Guaifenesin 600mg | 7 | 25 |
| Total, other adverse events | Placebo Matching Guaifenesin 600mg | 1 | 15 |
| Total, other adverse events | Guaifenesin 1200mg | 6 | 24 |
| Total, other adverse events | Placebo Matching Guaifenesin 1200mg | 3 | 14 |
| Total, serious adverse events | Guaifenesin 600mg | 0 | 25 |
| Total, serious adverse events | Placebo Matching Guaifenesin 600mg | 0 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01562548
GET https://conductscience.org/api/trials/v1/NCT01562548/results?page=2