A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 PR* in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain
18 Years
N/A
Both
Tumor, Pain
Trial Information
A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 PR* in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain
Normally chronic tumor related 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.
CG5503, a newly synthesized drug with an prolonged release (PR) formulation, also acts as a
centrally acting pain reliever but has a dual mode of action. The aim of this trial is to
investigate the effectiveness (level of pain control) and safety (side effects) of CG5503 PR
compared with no drug (placebo) and corresponding dose of morphine (an opioid commonly used
to treat tumor related pain). This trial is a randomized, double-blind (neither
investigator nor patient will know which treatment was received), active- and
placebo-controlled, parallel-group, multicenter trial.
The trial includes a 2 week titration phase starting with either 40 mg morphine (PR) bid or
100 mg CG5503 PR bid. Based on effectiveness and side effects subjects can up-titrate in
steps of 50 mg CG5503 PR (20 mg morphine PR) to a maximal dose of 250 mg CG5503 PR bid or
100 mg morphine PR bid. If subjects meet the stabilisation criteria at the end of the
titration phase they will be re-randomized to either placebo or active treatment and will
continue 4 weeks at the last dose level in the maintenance phase.
Assessments of pain relief include the pain intensity numeric rating scale (NRS), 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
Inclusion Criteria
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.
Exclusion Criteria
Key Exclusion Criteria:
- Subjects will be excluded from the study if they have a history of seizure disorder
or epilepsy;
- 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,
- thrombopenia, leukopenia or hypercalcemia,
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Proportion of subjects classified as responders. Responders are subjects who meet all of the following criteria: • Complete 28 days of the Maintenance phase • Have a mean pain intensity < 5.0 point on an 11-poi
Outcome Time Frame:
End of trial
Safety Issue:
No
Principal Investigator
Hans Georg Kress, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Clinic of Anaesthesiology and Pain Management, AKH Vienna
Authority:
Bulgaria: Bulgarian Drug Agency
Study ID:
761101
NCT ID:
NCT00472303
Start Date:
July 2007
Completion Date:
June 2012
Related Keywords:
- Tumor
- Pain
- Opioid
- Central acting analgesic
- CG5503 PR
- Tumor related pain
- Cancer related pain
- Morphine
- Pain assessment
- Placebo
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