Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246389
Status:
COMPLETED
Last Update Posted:
2011-02-18
First Post:
2005-10-28
Brief Title:
An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm
Sponsor:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Organization:
McNeil Consumer Specialty Pharmaceuticals a Division of McNeil-PPC Inc
Study Overview
Official Title:
Flexeril Cyclobenzaprine Hydrochloride Community Based Study - An Evaluation of Cyclobenzaprine HCl Monotherapy and in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg muscle spasm medication taken three times a day alone or in combination with ibuprofen 400 mg or 800 mg pain relief medication taken three times a day for the treatment of back or neck muscle pain with muscle spasm
Detailed Description:
The objective of this multicenter randomized open-label parallel-group one-week study is to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg three times a day for one week alone or in combination with ibuprofen 400 mg or 800 mg taken three times a day for acute back or neck muscle pain with muscle spasm The primary measurement of efficacy is the subject-rated global impression of change after seven days of treatment compared to baseline Safety assessments during the study include the monitoring of adverse events and a physical examination assessment of vital signs and medical history of any present illnesses conducted during the baseline visit The study hypothesis is that there will not be a statistically significant difference in patient ratings of global impression of change muscle spasm muscle pain medication helpfulness and functional ability between the cyclobenzaprine HCl monotherapy group versus the cyclobenzaprine HClibuprofen 400 mg and cyclobenzaprine HClibuprofen 800 mg groups for the treatment for acute back or neck muscle pain with spasm Patients receive cyclobenzaprine HCl 5 mg administered orally three times a day for one week or cyclobenzaprine HCl 5 mg with ibuprofen 400 mg administered orally three times a day for one week or cyclobenzaprine HCl 5 mg with ibuprofen 800 mg administered orally three times a day for one week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None