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.

Grünenthal GmbH0 sites432 target enrollmentJanuary 24, 2007

Overview

No summary available.

Registry

who.int

Start Date

January 24, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Female subjects 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.
•Subjects with a mean pain intensity \=5 points (11\-point NRS) on the day of randomization at the start of Titration phase.
•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

•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 eg, 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 CG5503 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 CG5503\.
•Trial Specific: