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

Chronic Pain Clinical Trial

Official title:

A Multicenter, Open-label, Randomized, Parallel Group Study to Compare the Efficacy and Safety of Sufentanil Transdermal System (TDS) With Sustained-Release Morphine Sulfate in Patients With Chronic Pain Due to Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00943566
• Other study ID #: STDS0901
• Status: Withdrawn
• Phase: Phase 2
• First received: July 21, 2009
• Last updated: September 14, 2015
• Start date: January 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2011
• Source: Labtec GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The primary objective of this study is to compare the consumption, in milligrams, of rescue analgesia (normal release morphine sulfate tablets) after the administration of sufentanil TDS or sustained release morphine sulfate.

The secondary efficacy objectives of this study are to evaluate:

• Pharmacokinetic data

• Adverse events

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female patients aged 18 to 75 with a diagnosis of cancer;

2. If female, is non-pregnant (negative pregnancy test at Visit 1) and non-lactating;

3. If female, is not of childbearing potential

4. 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;

5. Has been informed of the nature of the study and has provided written informed consent;

6. Is willing, able, and competent to complete the entire study and comply with study instructions

Exclusion Criteria:

1. Patient is a pregnant or lactating female (serum pregnancy test conducted at the Screening Visit);

2. Any ongoing serious adverse events (SAEs) at screening and at baseline;

3. Has scheduled elective surgery or other invasive procedures during the period of study participation;

4. Patients with a known intolerance to opioid analgesics or any excipient of the Investigational Product;

5. 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;

6. 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;

7. 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);

8. Patients with uncontrolled seizures;

9. Patients with increased intracranial pressure;

10. 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;

11. Patients with myxoedema, inadequately controlled hypothyroidism or Addisons disease;

12. History of alcohol and/or drug abuse (or a positive urine drug screen at Visit 1) within one year preceding the Screening Visit;

13. Active skin disease;

14. Patients suffering from diarrhea and/or opioid withdrawal;

15. Known positive Hepatitis B or C or HIV status;

16. Has participated in another clinical study of drugs or devices parallel to or < 1 month before study entry, or previous participation in this study;

17. Is an employee of the investigator or study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of the employees or the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Sufentanil
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).
• Sustained Release Morphine Sulfate
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Labtec GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events		18 days	Yes
Secondary	Pharmacokinetic data		6 days	No