Ignite Creation Date:
2024-05-06 @ 1:50 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01904149
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2013-07-17
Brief Title:
Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride
Sponsor:
Menarini Group
Organization:
Menarini Group
Study Overview
Official Title:
A Randomized Double-blind Placebo and Active-controlled Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain Following Abdominal Hysterectomy
Status:
COMPLETED
Status Verified Date:
2016-03
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:
DAVID lap
Brief Summary:
This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol DKP and tramadol hydrochloride TRAM in comparison to the single agents and placebo for the single dose phase only
Approximately 600 female patients presenting moderate to severe pain after a totalsubtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery
Approximately 600 female patients presenting moderate to severe pain after a totalsubtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery
Detailed Description:
In this clinical trial patients were randomized to the described 6 treatment arms where each arm define the treatment to be received in the first single dose phase lasting 8 hours after the 1st treatment intake and in the subsequent multiple-dose phase lasting from the second treatment intake up to the 8 hours after the last intake Namely
DKPTRAM followed by DKPTRAM
DKP followed by DKP
TRAM followed by TRAM
placebo followed by DKP
placebo followed by TRAM
placebo followed by DKPTRAM
The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group which resulted in the following 4 analysis groups DKPTRAM DEXKETOPROFEN TRAMADOL and Placebo
The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment which resulted in the following 3 analysis groups DKPTRAM DEXKETOPROFEN and TRAMADOL
DKPTRAM followed by DKPTRAM
DKP followed by DKP
TRAM followed by TRAM
placebo followed by DKP
placebo followed by TRAM
placebo followed by DKPTRAM
The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group which resulted in the following 4 analysis groups DKPTRAM DEXKETOPROFEN TRAMADOL and Placebo
The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment which resulted in the following 3 analysis groups DKPTRAM DEXKETOPROFEN and TRAMADOL
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 |
|---|---|---|---|
| 2012-004545-32 | EUDRACT_NUMBER | None | None |