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A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy

NCT00478023

CompletedPhase 3

Sponsor: Grünenthal GmbH

Conditions: Hysterectomy, Postoperative

Interventions: Morphine, CG5503 IR, CG5503 IR, CG5503 IR, Placebo

Countries: Hungary, Latvia, Poland, Romania, Russia, Serbia, Slovakia, Slovenia

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 overview

Sex: FEMALE

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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;
Locations (52)
  • Békéscsaba, Hungary
  • Debrecen, Hungary
  • Komárom, Hungary
  • Nyíregyháza, Hungary
  • Riga, Latvia
  • Riga, Latvia
  • Riga, Latvia
  • Riga, Latvia
  • Katowice, Poland
  • Krakow, Poland
  • Lodz, Poland
  • Lodz, Poland
  • Lublin, Poland
  • Lublin, Poland
  • Ruda Śląska, Poland
  • Warsaw, Poland
  • Warsaw, Poland
  • Wroclaw, Poland
  • Brasov, Romania
  • Brasov, Romania
  • Bucharest, Romania
  • Bucharest, Romania
  • Bucharest, Romania
  • Bucharest, Romania
  • Bucharest, Romania
  • Bucharest, Romania
  • Bucharest, Romania
  • Bucharest, Romania
  • Craiova, Romania
  • Ploieşti, Romania
  • + 22 more on CT.gov