Postoperative pain following abdominal hysterectomy MedDRA version: 8.1 Level: LLT Classification code 10000075 Term: Abdominal hysterectomy
Conditions
Interventions
R331333
Other descriptive name: (-)-(1R, 2R)-3-(3-dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
P
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial. 2. Female subjects 18 to 80 years of age. 3. Anesthesiological and surgical procedures performed according to protocol. 4. Women scheduled to undergo an abdominal hysterectomy with or without bilateral salpingo-oophorectomy due to uterine leiomyomas, or dysfunctional uterine bleeding or endometrial hyperplasia. 5. Moderate or severe baseline visceral pain on a verbal rating scale (VRS) within 6 hours following the last possible application of morphine s.c. (at 04:00). 6. Pain following hysterectomy of at least 4 on an 11-point numerical rating scale (NRS) within 6 hours following the last possible application of morphine s.c. (at 04:00). 7. American Society of Anesthesiologists (ASA) classification I-III. 8. Negative urine drugs-of-abuse test at the Screening Visit. Subjects who declare that they are receiving benzodiazepines for medical purposes may participate even if their test is positive for benzodiazepines. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General 1. Participation in another trial of IMPs or devices parallel to, or less than one month before trial entry. 2. Employees of the Investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center, as well as family members of the employees or the Investigator. 3. Known to or suspected of not being able to comply with the trial protocol. 4. Not able to communicate meaningfully with the Investigator and staff. 5. History of alcohol, medication or drug dependency, unstable psychological personality requiring intermittent or permanent treatment. 6. Psychiatric illness (subjects with well-controlled depression or anxiety disorder may participate if they are not taking any of the prohibited medications defined below), epilepsy or suicide risk. 7. History of seizure disorder or epilepsy suggested by the presence of any of the following: - Mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or - Severe traumatic brain injury, episode(s) of unconsciousness or posttraumatic amnesia of more than 24 hours’ duration within 15 years of screening. 8. Severely impaired renal function. 9. Subjects with moderately or severely impaired hepatic function, or subjects with laboratory values reflecting inadequate hepatic function (alanine aminotransaminase [ALT] and/or aspartate aminotransferase [AST] greater than three-fold upper limit of normal [ULN]). 10. Pregnant or breastfeeding woman. 11. History of chronic hepatitis B or C, or HIV, or presence of active hepatitis B or C within the past 3 months; history of AIDS. 12. Neuroleptics, monoamine oxidase inhibitors (MAOIs), serotonin norepinephrine re-uptake inhibitors (SNRIs), tricyclic antidepressants (TCA), anticonvulsants, antiparkinsonian drugs are prohibited within 14 days prior to the screening visit and during the trial. 13. Selective serotonin reuptake inhibitor (SSRI) treatments are allowed if taken for at least 30 days prior to trial start at unchanged dose. 14. Systemic steroid therapy, excluding inhalers, within 3 months prior to surgery. 15. Concomitant surgical procedures besides primary hysterectomy (eg, pelvic floor repair). 16. Concomitant inflammatory conditions including rheumatoid arthritis, Reiter’s syndrome, or systemic lupus erythematosus. 17. Evidence of active infections that may spread to other areas of the body (eg, osteomyelitis, pyogenic infection of the hip, overt infection, etc.). 18. Presence of known or suspected malignancy. 19. Need for postoperative intensive care in the ICU due to complication(s). 20. Use of disallowed i.v., i.m., spinal, epidural or oral analgesia or subjects likely to require prohibited concomitant therapy during the double-blind treatment and until the end of double-blind evaluation. 21. Planned postoperative wound infiltration up to the End of double-blind Evaluation. Trial specific: 1. Ongoing or known history of painful endometriosis. 2. Known or suspected chronic pelvic pain syndrome. 3. Vaginal hysterectomy. 4. Allergy or hypersensitivity to oxycodone, morphine, fentanyl, hydromorphone, heparin, or any compound planned to be used during the anesthesia. 5. Serious complication during surgery and up to randomization. 6. Allergy or hypersensitivity to oxycodone, morphine, fentanyl, hydromorphone, heparin, or any compound planned to be used during the anesthesia. 7. Pre-operative use within
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the efficacy and safety of multiple-dose application of three different oral doses of CG5503 IR compared to placebo and to assess safety and tolerability of CG5503 IR in women undergoing abdominal hysterectomy.;Secondary Objective: - To evaluate the tolerability of three different oral doses of CG5503 IR compared to placebo. - To explore the tolerability of three different oral doses of CG5503 IR compared to morphine IR. - To explore the multiple-dose analgesic efficacy of three different oral doses of CG5503 IR compared to morphine IR. - To describe the pharmacokinetics of CG5503 IR in the trial population.;Primary end point(s): The primary endpoint for this trial is the Sum of Pain Intensity Difference evaluated over 24 hours (SPID24). SPID24 will be calculated as the weighted sum of the scheduled pain intensity difference (difference between baseline at qualifying period and current pain intensity) collected up to 24 hours after the first dose of IMP. The weights will be taken as the time elapsed (in hours) since the previous measurement. | — |
Countries
Hungary, Latvia, Slovenia
Outcome results
None listed