Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02814565
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2016-06-23
Brief Title:
Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical andor Lower Back Pain Due to Muscle Spasms of Local Origin
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Parallel-Group Placebo-Controlled Multicenter Trial to Study the Efficacy and Safety of Cyclobenzaprine HCl Extended Release CER 15 mg in Subjects With Acute Cervical andor Lower Back Pain Due to Muscle Spasms of Local Origin
Status:
COMPLETED
Status Verified Date:
2019-01
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 was to assess the effect of cyclobenzaprine hydrochloride HCl extended release CER 15 mg capsule once daily in participants with muscle spasms associated with acute painful musculoskeletal conditions
Detailed Description:
The drug being tested in this study was cyclobenzaprine hydrochloride HCl extended-release CER CER was being tested to treat participants who had muscle spasms associated with acute painful musculoskeletal conditions This study looked at medication helpfulness relief from muscle spasms and pain and improvement in range of motion and daily living activities
The study enrolled 180 participants Participants were randomly assigned by chance like flipping a coin to one of the two treatment groups which remained undisclosed to the participant and study doctor during the study
CER 15 mg
Placebo dummy inactive pill - this was a capsule that looks like the study drug but had no active ingredient
All participants were asked to take one capsule at the same time each day throughout the study
This multi-center trial was conducted in the Russian Federation The overall time to participate in this study was up to 45 days Participants made multiple visits to the clinic and were contacted by telephone after the last dose of study drug for a follow-up assessment
The study enrolled 180 participants Participants were randomly assigned by chance like flipping a coin to one of the two treatment groups which remained undisclosed to the participant and study doctor during the study
CER 15 mg
Placebo dummy inactive pill - this was a capsule that looks like the study drug but had no active ingredient
All participants were asked to take one capsule at the same time each day throughout the study
This multi-center trial was conducted in the Russian Federation The overall time to participate in this study was up to 45 days Participants made multiple visits to the clinic and were contacted by telephone after the last dose of study drug for a follow-up assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1162-4846 | REGISTRY | WHO | None |