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

NCT ID: NCT00478023

Last Updated: 2019-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 854 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-04-30

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.

Detailed Description

Subjects undergoing abdominal hysterectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 3 dose levels of CG5503 IR compared with no drug (placebo) or one dose level of morphine (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment of acute pain after abdominal hysterectomy. The study will include a blinded 72 hour in-patient phase immediately following hysterectomy, during which subjects will be treated with either 50-, 75-, or 100-mg CG5503 IR, a matched placebo, or 20-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 24 hours (using the mean SPID at 24 hours).

Conditions

Hysterectomy; Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Morphine

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

20 mg IR; 4 - 6 hourly; Total 72 hours

Tapentadol 50 mg immediate release

Group Type: EXPERIMENTAL

CG5503 IR

Intervention Type: DRUG

50mg; 4 - 6 hourly; Total 72 hours

Tapentadol 75 mg immediate release

Group Type: EXPERIMENTAL

CG5503 IR

Intervention Type: DRUG

75mg; 4 -6 hourly; Total 72 hours

Tapentadol 100 mg immediate release

Group Type: EXPERIMENTAL

CG5503 IR

Intervention Type: DRUG

100mg, 4 - 6 hourly; Total 72 hours

Matched placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

4 - 6 hourly; Total 72 hours

Interventions

Morphine

20 mg IR; 4 - 6 hourly; Total 72 hours

Intervention Type: DRUG

CG5503 IR

50mg; 4 - 6 hourly; Total 72 hours

Intervention Type: DRUG

CG5503 IR

75mg; 4 -6 hourly; Total 72 hours

Intervention Type: DRUG

CG5503 IR

100mg, 4 - 6 hourly; Total 72 hours

Intervention Type: DRUG

Placebo

4 - 6 hourly; Total 72 hours

Intervention Type: DRUG

Other Intervention Names

Tapentadol; Tapentadol; Tapentadol

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomasz Rechberger, Prof.

Role: PRINCIPAL_INVESTIGATOR

Samodzielny Publiczny Szpital

Locations

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

Countries

Hungary; Latvia; Poland; Romania; Russia; Serbia; Slovakia; Slovenia; Ukraine

Other Identifiers

731200

Identifier Type: -

Identifier Source: org_study_id