Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00364247
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2006-08-11
Brief Title:
A Study to Evaluate the Effectiveness and Safety of TapentadolCG5503 in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Active- and Placebo-Controlled Parallel-Group Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy Followed by a Voluntary Open-Label Extension
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 level of pain control and safety of the administration of 3 different dose levels of CG5503 compared with oxycodone and with placebo in patients who have had a bunionectomy and to assess the safety of the drug for 9 days after patients are discharged from the hospital
Detailed Description:
Patients undergoing bunionectomy often experience moderate to severe acute pain post-surgery Normally such pain is controlled when patients 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 CG5503 a newly synthesized drug also acts as a centrally acting analgesic 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 Immediate Release IR compared to no drug placebo or one dose level of oxycodone an opioid commonly used to treat post-surgical pain This study is a randomized patients are assigned different treatments based on chance double-blind neither investigator nor patient will know which treatment is received active- and placebo-controlled parallel-group multicenter study to evaluate treatment of the acute pain from bunionectomy The study will include a blinded 72 hour inpatient phase immediately following bunionectomy during which patients will be treated with either 50- 75- or 100-mg CG5503 IR base a placebo or 15-mg oxycodone IR and pain intensity and pain relief will be periodically assessed Following this phase patients wishing to continue treatment with CG5503 IR may enter an outpatient voluntary nonrandomized open-label extension phase for 9 days when they will receive 50- or 100-mg CG5503 IR 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 oxycodone The null hypothesis for the study is that efficacy results for all CG5503 IR dosage groups are equal to placebo based on the mean sum of pain intensity difference at 48 hours The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours CG5503 IR 50 or 75 or 100 mg of the base or oxycodone 15 mg or placebo 1 capsule taken every 4 to 6 hours during the 72-hour postsurgery phase of the study and CG5503 50 mg capsules 1 to 2 tablets taken by mouth every 4 to 6 hours for up to 9 days during the open label portion of the study All doses of study treatment will be taken with approximately 120 mL of water with or without food
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