Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472303
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2007-05-10
Brief Title:
A Study to Evaluate Tapentadol CG5503 in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine
Sponsor:
Grünenthal GmbH
Organization:
Grünenthal GmbH
Study Overview
Official Title:
A Randomized Withdrawal Active- and Placebo-controlled Double-blind Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 Tapentadol PR in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain
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 purpose of this study will be to determine whether tapentadol CG5503 is effective and safe in the treatment of chronic tumor related pain compared to placebo In addition tapentadol CG5503 will also be compared to morphine controlled release also referred to as slow release SR
Tapentadol prolonged-release PR is the term used in the European Union and is referred to as extended release ER in the United States
Tapentadol prolonged-release PR is the term used in the European Union and is referred to as extended release ER in the United States
Detailed Description:
Normally chronic tumor related pain is controlled when participants 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 prolonged release PR formulation also acts as a centrally acting pain reliever but has 2 mechanisms of action The aim of this trial is to investigate the effectiveness level of pain control and safety side effects of tapentadol CG5503 PR compared with no drug placebo and corresponding dose of morphine an opioid commonly used to treat tumor related pain This trial is a randomized double-blind neither investigator nor patient will know which treatment was received active- and placebo-controlled parallel-group randomized withdrawal design multicenter trial
The trial includes a 2 week titration phase starting with either 40 mg morphine PR bid bid twice daily dosing one dose in the morning and one dose in the evening or 100 mg tapentadol CG5503 PR bid Based on effectiveness and side effects subjects can up-titrate in steps of 50 mg tapentadol CG5503 PR to a maximal dose of 250 mg tapentadol CG5503 PR bid or 100 mg morphine PR bid If participants meet the stabilisation criteria at the end of the titration phase they will be re-randomized to either placebo or active treatment and will continue 4 weeks at the last dose level in the maintenance phase Only participants on tapentadol in the titration phase will be re-randomized to either matching placebo or to tapentadol To maintain the blinding nature of the trial participants in the morphine arm during the titration phase will also be re-randomized however they will all remain on morphine controlled release in the maintenance phase Placebo to match tapentadol tablets as well as placebo to match morphine capsules will be used to mask the treatment allocation
Participants will be issued with an electronic diary eDiary to capture Numeric Rating Scale NRS pain intensities
Assessments of pain relief include the pain intensity numeric rating scale NRS and patient global impression of change PGIC Safety evaluations include monitoring of adverse events physical examinations clinical laboratory tests and electrocardiograms Venous blood samples will be collected for the determination of serum concentrations of tapentadol CG5503
The trial includes a 2 week titration phase starting with either 40 mg morphine PR bid bid twice daily dosing one dose in the morning and one dose in the evening or 100 mg tapentadol CG5503 PR bid Based on effectiveness and side effects subjects can up-titrate in steps of 50 mg tapentadol CG5503 PR to a maximal dose of 250 mg tapentadol CG5503 PR bid or 100 mg morphine PR bid If participants meet the stabilisation criteria at the end of the titration phase they will be re-randomized to either placebo or active treatment and will continue 4 weeks at the last dose level in the maintenance phase Only participants on tapentadol in the titration phase will be re-randomized to either matching placebo or to tapentadol To maintain the blinding nature of the trial participants in the morphine arm during the titration phase will also be re-randomized however they will all remain on morphine controlled release in the maintenance phase Placebo to match tapentadol tablets as well as placebo to match morphine capsules will be used to mask the treatment allocation
Participants will be issued with an electronic diary eDiary to capture Numeric Rating Scale NRS pain intensities
Assessments of pain relief include the pain intensity numeric rating scale NRS and patient global impression of change PGIC Safety evaluations include monitoring of adverse events physical examinations clinical laboratory tests and electrocardiograms Venous blood samples will be collected for the determination of serum concentrations of tapentadol CG5503
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KF550315 | OTHER | Grünenthal | None |
| 2006-004997-28 | EUDRACT_NUMBER | None | None |