Phase 3
N=854
A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
Hysterectomy · Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT00478023 ↗Enrolled (actual)
854
Serious AEs
0.5%
Results posted
Jan 2010
Primary outcome: Primary: Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. — 48.8; 49.0; 52.4; 52.9 units on scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Morphine (Drug); CG5503 IR (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Grünenthal GmbH
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. |
48.8; 49.0; 52.4; 52.9; 29.0 | <0.0001 sig |
| SECONDARY Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity |
116.6; 112.4; 120.6; 123.5; 71.1 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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;
Data sourced from ClinicalTrials.gov (NCT00478023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.