A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
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
1 other identifier
interventional
854
8 countries
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2007
Shorter than P25 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 23, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
January 27, 2010
CompletedOctober 28, 2019
October 1, 2019
9 months
May 23, 2007
December 16, 2009
October 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.
Pain Intensity assessed at predefined time points over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \[baseline-post baseline\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain, assuming patients start with a baseline value of 10 and all subsequent values will be 0).
Baseline to 24 hours after first intake of study drug
Secondary Outcomes (1)
Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity
Baseline value to 48 hours after first study drug intake.
Study Arms (5)
Morphine
ACTIVE COMPARATORTapentadol 50 mg immediate release
EXPERIMENTALTapentadol 75 mg immediate release
EXPERIMENTALTapentadol 100 mg immediate release
EXPERIMENTALMatched placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Female between 18 and 80 years of age;
- Scheduled to undergo an abdominal hysterectomy with or without bilateral salpingo-oophorectomy due to uterine leiomyomas, or dysfunctional uterine bleeding or endometrial hyperplasia;
- Anesthesiological and surgical procedures performed according to protocol;
- Moderate or severe baseline pain following hysterectomy on a Verbal Rating Scale (VRS) within 6 hours following the last possible application of morphine subcutaneous;
- Pain following hysterectomy of at least 4 on an 11-point Numeric Rating Scale (NRS) within 6 hours following the last possible application of morphine subcutaneous;
- American Society of Anesthesiologists (ASA) classification I-III.
You may not qualify if:
- Vaginal hysterectomy;
- Ongoing or known history of painful endometriosis;
- Known or suspected chronic pelvic pain syndrome;
- Previous abdominal or pelvic open surgery;
- History of seizure disorder or epilepsy;
- History of alcohol or drug abuse;
- Evidence of active infections that may spread to other areas of the body;
- severely impaired renal function, moderately or severely impaired hepatic function,
- Allergy or hypersensitivity to oxycodone, morphine, fentanyl hydromorphone, heparin, or any compound planned to be used during the anesthesia;
- Serious complication during surgery and up to randomization;
- Pre-operative use within 12hours prior to surgery or peri-operative use of non-steroidal anti-inflammatory drugs (NSAIDs);
- Treated regularly with opioid analgesic or non-steroidal anti-inflammatory drugs (NSAIDs) within 30 days prior to screening;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Site 13
Békéscsaba, Hungary
Site 14
Debrecen, Hungary
Site 15
Komárom, Hungary
Site 12
Nyíregyháza, Hungary
Site 16
Riga, Latvia
Site 17
Riga, Latvia
Site 18
Riga, Latvia
Site 19
Riga, Latvia
Site 27
Katowice, Poland
Site 23
Krakow, Poland
Site 24
Lodz, Poland
Site 66
Lodz, Poland
Site 22
Lublin, Poland
Site 25
Lublin, Poland
Site 26
Ruda Śląska, Poland
Site 20
Warsaw, Poland
Site 21
Warsaw, Poland
Site 28
Wroclaw, Poland
Site 33
Brasov, Romania
Site 78
Brasov, Romania
Site 29
Bucharest, Romania
Site 30
Bucharest, Romania
Site 31
Bucharest, Romania
Site 32
Bucharest, Romania
Site 34
Bucharest, Romania
Site 35
Bucharest, Romania
Site 36
Bucharest, Romania
Site 76
Bucharest, Romania
Site 75
Craiova, Romania
Site 61
Ploieşti, Romania
Site 71
Belgorod, Russia
Site 37
Moscow, Russia
Site 38
Moscow, Russia
Site 44
Moscow, Russia
Site 73
Moscow, Russia
Site 42
Saint Petersburg, Russia
Site 43
Saint Petersburg, Russia
Site 45
Belgrade, Serbia
Site 47
Belgrade, Serbia
Site 46
Kragujevac, Serbia
Site 70
Novi Sad, Serbia
Site 48
Banská Bystrica, Slovakia
Site 51
Bratislava, Slovakia
Site 52
Bratislava, Slovakia
Site 62
Košice, Slovakia
Site 50
Martin, Slovakia
Site 53
Maribor, Slovenia
Site 64
Donetsk, Ukraine
Site 55
Kiev, Ukraine
Site 56
Kiev, Ukraine
Site 58
Kiev, Ukraine
Site 67
Zaporizhya, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Approval to conduct the trial was obtained in Slovenia. No Slovenian subjects were exposed to study drug.
Results Point of Contact
- Title
- Claudia Leinweber
- Organization
- Grunenthal GmbH
Study Officials
- PRINCIPAL INVESTIGATOR
Tomasz Rechberger, Prof.
Samodzielny Publiczny Szpital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2007
First Posted
May 24, 2007
Study Start
May 1, 2007
Primary Completion
February 1, 2008
Study Completion
April 1, 2008
Last Updated
October 28, 2019
Results First Posted
January 27, 2010
Record last verified: 2019-10