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

This study has been withdrawn prior to enrollment.
(funding for project discontinued)
Sponsor:
Information provided by:
Labtec GmbH
ClinicalTrials.gov Identifier:
NCT00943566
First received: July 21, 2009
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Drug: Sufentanil
Drug: Sustained Release Morphine Sulfate
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Labtec GmbH:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 18 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic data [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sufentanil Transdermal Delivery System
Experimental drug
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).
Active Comparator: Control
Sustained release morphine sulfate
Drug: 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)

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Peter Klaffenbach, PhD, Labtec GmbH
ClinicalTrials.gov Identifier: NCT00943566     History of Changes
Other Study ID Numbers: STDS0901
Study First Received: July 21, 2009
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Labtec GmbH:
Pain
Cancer
Morphine

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Morphine
Sufentanil
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014