Exploratory Efficacy Study of Guaifenesin in Upper Back Pain

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01562548

First received: March 22, 2012

Last updated: May 1, 2014

Last verified: March 2014

History of Changes

Results First Received: March 6, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Upper Back Pain
Interventions:	Drug: Guaifenesin Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at multiple clinical sites

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg
STARTED	25	15	25	14
COMPLETED	25	15	24	14
NOT COMPLETED	0	0	1	0
Lost to Follow-up	0	0	1	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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
Total	Total of all reporting groups

Baseline Measures

	Guaifenesin 600mg	Placebo Matching Guaifenesin 600mg	Guaifenesin 1200mg	Placebo Matching Guaifenesin 1200mg	Total
Number of Participants [units: participants]	25	15	24	14	78
Age [units: Years] Mean (Standard Deviation)	47.2 (11.87)	43.8 (10.35)	45.3 (10.62)	47.3 (13.92)	45.9 (11.47)
Gender [units: Participants]
Female	8	9	12	6	35
Male	17	6	12	8	43

Outcome Measures

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1. Primary:

Mean Change From Baseline of Both AM and PM Spasm Assessment Scores [ Time Frame: 7 Days ]

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2. Secondary:

Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores [ Time Frame: 7 Days ]

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3. Secondary:

Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores [ Time Frame: 7 Days ]

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4. Secondary:

Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores [ Time Frame: 7 Days ]

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5. Secondary:

Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores [ Time Frame: 7 Days ]

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6. Secondary:

Muscle Relaxation Scores [ Time Frame: 4 Days, 7 Days ]

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7. Secondary:

Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores [ Time Frame: Before treatment, 4 Days, 7 Days ]

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8. Secondary:

Global Assessment of Treatment Helpfulness (GATH) [ Time Frame: 4 Days, 7 Days ]

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9. Secondary:

Global Assessment of Sleep Disturbance (GASD) [ Time Frame: 7 Days ]

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10. Secondary:

Global Assessment of Headache Frequency (GAHF) [ Time Frame: 7 Days ]

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11. Secondary:

Global Assessment of Headache Intensity (GAHI) [ Time Frame: 7 Days ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01562548 History of Changes
Other Study ID Numbers:	A3940666
Study First Received:	March 22, 2012
Results First Received:	March 6, 2014
Last Updated:	May 1, 2014
Health Authority:	United States: Food and Drug Administration

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