A multicentre, randomized, open label, parallel group pilot study comparing efficacy and safety of sufentanil transdermal delivery system (TDS) to oral sustained release morphine sulphate in patients with chronic cancer pai

Phase 1

• Conditions: Chronic cancer pain; MedDRA version: 14.0Level: PTClassification code 10058019Term: Cancer painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2010-023207-10-SK
• Lead Sponsor: hameln rds a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-31
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Male or female patients aged 18 to 75 with a diagnosis of cancer;
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;
Stable but inadequately controlled pain (with present breakthrough pain attacks) with current therapy for at least two weeks;
Pain intensity, as assessed by the pain intensity numerical rating scale during Visit 1, meets the definition of „moderate (score of 4-5) or „severe (score of 6-10) pain;
Life expectancy of more than 3 months;
Male, or female patients with childbearing potential who must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation;
Ability to understand and willingness to sign a written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Known hypersensitivity or intolerance to opioid analgesics or any excipient of the investigational products;
Planned initiation of chemotherapy, radiotherapy, or bisphosphonates treatment during the course of the study or within 30 days prior to randomization;
Scheduled elective surgery or other invasive procedures during the period of study participation;
Received an investigational drug within 30 days prior to screening or who is scheduled to receive an other investigational drug during the course of the study;
Any ongoing serious adverse events (SAEs) at screening;
Respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, (obstructive) sleep apnea syndrome, paralytic ileus;
Known history of uncontrolled seizures, increased intracranial pressure;
Evidence of clinically significant cardiovascular, renal, hepatic, CNS 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 laboratory findings during screening (these patients will be not randomized): aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT) levels more than 3 times the upper level of normal; total bilirubin level more than 1.5 times the upper level of normal creatinine clearance less than 50 ml/min (calculated using the Cockcroft-Gault formula);
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;
Taking lidocaine, mexiletine or other anaesthetics;
Use of scopolamine, acetylcholinesterase-inhibiting drugs, beta-blockers and antiarrythmic drugs;
Patients with myxoedema, inadequately controlled hypothyroidism or Addisons disease;
Active skin disease;
Patients suffering from diarrhea and/or opioid withdrawal;
Known positive Hepatitis B or C or HIV status;
History of alcohol and/or drug abuse within one year preceding the Screening Visit;
Patients who are pregnant, breast feeding or women of childbearing potential. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of reproductive potential, to include female partners of heterosexual or bisexual patients, must agree to use an effective method of contraception during the study and for up to three months following termination of the study.
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.
Unwilling or unable to comply with the protocol
Any other condition that, in the opinion of the investigator, is likely to interfere with the successful collection of the measures required for the study or poses a risk to the patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified