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A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine

NCT00505414

TerminatedPhase 3

Sponsor: Grünenthal GmbH

Conditions: Pain, Neoplasm, Cancer

Interventions: Tapentadol in the Titration Phase, Morphine in the Maintenance Phase, Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase, Tapentadol in the Maintenance Phase, Morphine in the Titration Phase

Countries: United States, Argentina, Chile, France, Latvia, Ukraine

The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* A signed informed consent document.
* Male and non-pregnant, non-lactating female subjects.
* Female subjects must be post menopausal, surgically sterile, or practicing an effective method of birth control and continue to do so throughout the trial.
* At least 18 years of age.
* Have chronic malignant tumor-related pain
* Are opioid-naïve or have been pretreated with an equianalgesic dose range equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior treatment.
* Have a mean pain intensity of at least 5 points on an 11-point Numeric Rating Scale (where 0 indicates no pain and 10 indicates worst possible pain).
* Have an expected course of the disease such that the pain that will permit compliance with the trial protocol over the entire trial period.

Exclusion Criteria:

* Have a life-long history of seizure disorder or epilepsy.
* Have had any of the following within one year: mild/moderate traumatic brain injury, stroke, and transient ischemic attack.
* Have had severe traumatic brain injury within 15 years (consisting of ≥ 1 of the following: brain contusion, intracranial hematoma, and either unconsciousness or post-traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness.
* Have a known history and/or presence of cerebral metastases.
* Have moderately or severely impaired hepatic function.
* Have laboratory values reflecting inadequate hepatic function.
* Have thrombopenia, leucopenia or hypercalcemia
* Have severely impaired renal function.
* Having uncontrolled hypertension
* Having clinically relevant history of hypersensitivity, allergy or contraindications to morphine or any of the excipients.
* Have chronic hepatitis B or hepatitis C, or Human Immunodeficiency Virus (HIV).
* Subjects currently undergoing the following concomitant therapy: radiotherapy, pain inducing chemotherapy, anti-parkinsonian drugs, neuroleptics, monoamine oxidase inhibitors, serotonin norepinephrine re-uptake inhibitors (SNRI) or any other analgesic therapy than investigational medication or rescue medication during the trial. Selective serotonin re-uptake inhibitor (SSRI) treatments are allowed if taken for at least 30 days before the screening period of the trial at an unchanged dose.

Locations (37)

St. Petersburg, Florida, United States
Elkhart, Indiana, United States
Shreveport, Louisiana, United States
Cedarhurst, New York, United States
Glens Falls, New York, United States
Winston-Salem, North Carolina, United States
Canton, Ohio, United States
La Plata, Buenos Aires, Argentina
Pergamino, Buenos Aires, Argentina
Quilmes, Buenos Aires, Argentina
Villa Domínico, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Ciudad de Buenos Aires, Argentina
Santa Fe, Argentina
Coquimbo, Chile
Santiago, Chile
Santiago, Chile
Santiago, Chile
Talcahuano, Chile
Temuco, Chile
Valparaíso, Chile
Nice, France
Orléans, France
Villejuif, France
Daugavpils, Latvia
Riga, Latvia
Cherkasy, Ukraine
Donetsk, Ukraine
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