Status:
COMPLETED
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine
Lead Sponsor:
Grünenthal GmbH
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Tumor
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) wil...
Detailed Description
Normally chronic tumor related pain is controlled when participants receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiti...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male and non-pregnant, non-lactating female subjects.
- Of at least 18 years of age with chronic malignant tumor-related pain with a mean pain intensity (NRS) of 5 points or higher.
- Subjects who are opioid-naïve or pretreated with an equianalgesic dose range equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior treatment.
- Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the trial.
- Expected course of the disease and the pain that would permit compliance with the trial protocol over the entire trial period.
- Exclusion Criteria
- Key Exclusion Criteria:
- Subjects will be excluded from the study if they have a history of seizure disorder or epilepsy;
- known history and/or presence of cerebral tumor or cerebral metastases.
- history of alcohol or drug abuse;
- uncontrolled hypertension,
- clinical laboratory values reflecting severe renal insufficiency,
- moderate or severe hepatic impairment,
- hepatitis B or C, HIV,
- inadequate bone marrow reserve
- currently treated with radiotherapy,
- pain-inducing chemotherapy,
- anti-parkinsonian drugs, neuroleptics, monoamine oxidase inhibitors, serotonin norepinephrine reuptake inhibitor (SNRI) or any other analgesic therapy than investigational medication or rescue medication during the trial.
- selective serotonin reuptake inhibitor (SSRI) treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose.
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
622 Patients enrolled
Trial Details
Trial ID
NCT00472303
Start Date
July 1 2007
End Date
June 1 2012
Last Update
November 4 2019
Active Locations (71)
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1
Site 043004
Klagenfurt, Austria, 9020
2
Site 043002
Vienna, Austria, 1020
3
Site 043001
Vienna, Austria, 1090
4
Site 043005
Vienna, Austria, 1100