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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pain, Neoplasm, Cancer

In brief

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.

Key facts

Study ID: NCT00505414
Run by: Grünenthal GmbH
People needed: 136
Starts: 2007-06-01
Expected to finish: 2009-05-01
Last updated by the study team: 2019-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

001013 — St. Petersburg, Florida, United States
001002 — Elkhart, Indiana, United States
001001 — Shreveport, Louisiana, United States
001010 — Cedarhurst, New York, United States
001003 — Glens Falls, New York, United States
001004 — Winston-Salem, North Carolina, United States
001015 — Canton, Ohio, United States
054003 — La Plata, Buenos Aires, Argentina
054012 — Pergamino, Buenos Aires, Argentina
054022 — Quilmes, Buenos Aires, Argentina
054008 — Villa Domínico, Buenos Aires, Argentina
054010 — Rosario, Santa Fe Province, Argentina
054013 — Rosario, Santa Fe Province, Argentina
054005 — San Miguel de Tucumán, Tucumán Province, Argentina
54009 — Ciudad de Buenos Aires, Argentina
054015 — Santa Fe, Argentina
056006 — Coquimbo, Chile
056011 — Santiago, Chile
056008 — Santiago, Chile
056005 — Santiago, Chile
056003 — Talcahuano, Chile
056004 — Temuco, Chile
056012 — Valparaíso, Chile
033002 — Nice, France
033015 — Orléans, France

Full record on ClinicalTrials.gov

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