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

NCT00943566 | Withdrawn Phase 2

• 1 other identifier: STDS0901
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Pain

Keywords

Pain; Cancer; Morphine

Outcome Measures

Primary Outcomes (1)

• 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.

  6 days

Secondary Outcomes (2)

• Adverse events

  18 days

• Pharmacokinetic data

  6 days

Study Arms (2)

Sufentanil Transdermal Delivery System

EXPERIMENTAL

Experimental drug

Drug: Sufentanil

Control

ACTIVE COMPARATOR

Sustained release morphine sulfate

Drug: Sustained Release Morphine Sulfate

Interventions

Sufentanil DRUG

Transdermal Delivery System; Apply up to six 3 cm2 sufentanil TDS patches every 3 days for 12 days of observation. The 12 days of observation begin after a 7 day conversion to sustained release morphine sulfate. If the subject continues on the pharmacokinetic portion of the study, an additional 6 days of intervention will be evaluated (at the same dose as the primary efficacy study).

Sufentanil Transdermal Delivery System

Sustained Release Morphine Sulfate DRUG

Sustained Release Morphine Sulfate tablets every 12 hours; up to 400 mg every day for 19 days (7 days of conversion to sustained release morphine sulfate and 12 days of observation)

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Patients with increased intracranial pressure;
• Patients who are receiving hypnotics or other central nervous system (CNS) depressants that, in the opinion of the investigator, may pose a risk of additional CNS depression with opioid medication;
• Patients with myxoedema, inadequately controlled hypothyroidism or Addisons disease;
• History of alcohol and/or drug abuse (or a positive urine drug screen at Visit 1) within one year preceding the Screening Visit;
• Active skin disease;
• Patients suffering from diarrhea and/or opioid withdrawal;
• Known positive Hepatitis B or C or HIV status;

Sponsors & Collaborators

• Labtec GmbH: lead

MeSH Terms

Conditions

Chronic Pain; Pain; Neoplasms

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: September 15, 2015

Record last verified: 2011-06