WithdrawnPhase 2

A Safety and Efficacy Study of Sufentanil Transdermal System in Patients With Chronic Pain Due to Cancer

Stopped: funding for project discontinued

0Started 2010-01

Plain-language summary

The study hypothesis is that the safety and efficacy of sufentanil following transdermal application is comparable to sustained release morphine sulphate tablets in patients with chronic pain due to cancer.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patients aged 18 to 75 with a diagnosis of cancer;
✓. If female, is non-pregnant (negative pregnancy test at Visit 1) and non-lactating;
✓. If female, is not of childbearing potential
✓. Documented history of moderate to severe chronic cancer pain requiring around-the-clock therapy and are likely to benefit from WHO step III opioid analgesics for the duration of the study;
✓. Has been informed of the nature of the study and has provided written informed consent;
✓. Is willing, able, and competent to complete the entire study and comply with study instructions

Exclusion criteria

✕. Patient is a pregnant or lactating female (serum pregnancy test conducted at the Screening Visit);
✕. Any ongoing serious adverse events (SAEs) at screening and at baseline;
✕. Has scheduled elective surgery or other invasive procedures during the period of study participation;
✕. Patients with a known intolerance to opioid analgesics or any excipient of the Investigational Product;
✕. Patients with respiratory depression with hypoxia and/or hypercapnia, sever chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus, (obstructive) sleep apnea syndrome;
✕. Evidence of clinically significant cardiovascular, renal, hepatic or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the patient at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the results;
✕. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (\> 3 times the upper level of normal) or an abnormal total bilirubin level (\> 1.5 times the upper level of normal) or creatinine clearance \< 50 ml/min (calculated using the Cockcroft-Gault formula);
✕. Patients with uncontrolled seizures;

What they're measuring

The consumption (in mg) of rescue analgesia (normal release morphine sulfate tablets) per day after the administration of either sufentanil TDS or SR morphine sulfate.

Timeframe: 6 days

Trial details

NCT IDNCT00943566

SponsorLabtec GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-12

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