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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00478023
• Date of registration: 23/05/2007
• Prospective Registration: No
• Primary sponsor: Grünenthal GmbH
• Public title: A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
• Scientific title: 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
• Date of first enrolment: May 2007
• Target sample size: 854
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00478023
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Croatia, Former Serbia and Montenegro, Hungary, Latvia, Poland, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Ukraine

Contacts

• Name: Tomasz Rechberger, Prof.
• Affiliation: Samodzielny Publiczny Szpital

Key inclusion & exclusion 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;



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hysterectomy

Postoperative

Intervention(s)

Drug: Placebo

Drug: Morphine

Drug: CG5503 IR

Primary Outcome(s)

Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity. [Time Frame: Baseline to 24 hours after first intake of study drug]

Secondary Outcome(s)

Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity [Time Frame: Baseline value to 48 hours after first study drug intake.]

Secondary ID(s)

731200

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results

• Results available: Yes
• Date Posted: 27/01/2010
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00478023