Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478023
Status:
COMPLETED
Last Update Posted:
2019-10-28
First Post:
2007-05-23
Brief Title:
A Study to Evaluate the Efficacy and Safety of Tapentadol CG5503 in the Treatment of Acute Pain After Abdominal Hysterectomy
Sponsor:
Grünenthal GmbH
Organization:
Grünenthal GmbH
Study Overview
Official Title:
A Randomized Double-blind Parallel-arm Placebo- and Comparator- Controlled Trial of the Efficacy and Safety of Multiple Doses of Immediate-release IR CG5503 for Postoperative Pain Following Abdominal Hysterectomy
Status:
COMPLETED
Status Verified Date:
2019-10
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 main objective of this study is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR tapentadol immediate release compared to placebo in women undergoing abdominal hysterectomy
Detailed Description:
Subjects undergoing abdominal hysterectomy often experience moderate to severe acute pain post-surgery Normally such pain is controlled when subjects receive repeated doses of opioid analgesics However opioid therapy is commonly associated with side effects such as nausea vomiting sedation constipation addiction tolerance and respiratory depression Tapentadol CG5503 a newly synthesized drug with an immediate release IR formulation also acts as a centrally acting pain reliever but has a dual mode of action The aim of this study is to investigate the effectiveness level of pain control and safety side effects of 3 dose levels of CG5503 IR compared with no drug placebo or one dose level of morphine an opioid commonly used to treat post-surgical pain This study is a randomized double-blind neither investigator nor patient will know which treatment was received active- and placebo-controlled parallel-group multicenter study to evaluate the treatment of acute pain after abdominal hysterectomy The study will include a blinded 72 hour in-patient phase immediately following hysterectomy during which subjects will be treated with either 50- 75- or 100-mg CG5503 IR a matched placebo or 20-mg morphine and pain relief will be periodically assessed Assessments of pain relief include the pain intensity numeric rating scale PI pain relief numeric rating scale PAR and patient global impression of change scale PGIC Safety evaluations include monitoring of adverse events physical examinations and clinical laboratory tests Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 24 hours using the mean SPID at 24 hours
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