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 - n.a.

• Conditions: malignant tumor related pain; MedDRA version: 14.0Level: PTClassification code 10058019Term: Cancer painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2006-004997-28-BG
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-14
• Last Update Posted: 14 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

• 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.
• Male and non-pregnant, non-lactating female subjects. Sexually
active women must be post menopausal, surgically sterile, or
practicing an effective method of birth control (e.g., prescription
oral contraceptives, contraceptive injections, intrauterine device,
double barrier method, contraceptive patch, male partner
sterilization) before entry and throughout the trial. Female subjects
of childbearing potential must have a negative pregnancy test at
Screening.
• At least 18 years of age.
• Chronic malignant tumor-related pain.
• 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.
[For Hungary (Amendment 1-1) the inclusion criterion reads:
Subjects who are dissatisfied with prior treatment and requiring
analgesia equivalent to a maximum of 160 mg oral morphine per
day].
• Subjects with a pain intensity =5 points (11-point NRS) on the day
of randomization at the start of Titration phase (Visit 2).
• Expected course of the disease and the pain that will permit
compliance with the trial protocol over the entire trial period.
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

General:
• History of alcohol and/or drug abuse in the investigator’s judgment,
based on patient history and physical examination.
• The subject has a clinically significant disease other than cancer
which in the investigator's opinion may affect efficacy or safety
assessments e.g., significant unstable cardiac, vascular, pulmonary,
gastrointestinal, endocrine, neurological, psychiatric (resulting in
disorientation, memory impairment or inability to report accurately)
or metabolic disturbances.
• Any scheduled surgery during the trial.
• Any painful procedure during the trial that may, in the opinion of the
Investigator, affect the efficacy or safety assessments.
• 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.
• Known to or suspected of not being able to comply with the protocol
and the use of tapentadol or morphine.
• Have received an experimental drug or used an experimental
medical device within 30 days before the planned start of treatment.
• Participation in another trial concurrently.
• Subjects who have participated in previous trials of tapentadol.
Trial Specific:
• Life-long history of seizure disorder or epilepsy, or any of the
following within one year: mild/moderate traumatic brain injury,
stroke, transient ischemic attack, or severe traumatic brain injury
within 15 years (consisting of =1 of the following: brain contusion,
intracranial hematoma, either unconsciousness or post-traumatic
amnesia lasting for more than 24 hours) or with residual sequelae
suggesting transient changes in consciousness.
• Known history and/or presence of cerebral tumor or cerebral
metastases.
• Subjects with moderately or severely impaired hepatic function, or
subjects with an ALT and/or AST greater than three-fold the upper
limit of normal.
• Inadequate baseline bone marrow reserve with WBC
count =3 500/µL, platelet count =100 000/µL, and
hemoglobin level =9.5 g/dL.
• Subjects with severely impaired renal function.
• Subjects with hypercalcemia, i.e., corrected total serum calcium
levels higher than 3.0 mmol/L.
• Subjects taking any prohibited concomitant medications (as
specified below)
• Uncontrolled hypertension (repeated measurements of systolic blood
pressure >160 mmHg or diastolic blood pressure >95 mmHg).
• Clinically relevant history of hypersensitivity, allergy or
contraindications to tapentadol or morphine or any of the excipients.
• Chronic hepatitis B or C, or HIV, or presence of active hepatitis B or
C within the past 3 months.
[For Switzerland (Amendment 1-2) the exclusion criterion reads:
Chronic hepatitis B or C, or HIV (known by history) , or presence of
active hepatitis B or C within the past 3 months]

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified