A randomised, 2-arm, parallel group study assessing efficacy and tolerability of titrated transdermal buprenorphine in patients with moderate to severe chronic non malignant pain - Titrated transdermal buprenorphine patch in moderate to severe chronic pai

• Conditions: Moderate to severe chronic pain

• Registration Number: EUCTR2005-005365-11-AT
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-23
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

- At least 18 years of age at enrolment
- Subjects suffering from chronic non-malignant pain (of at least 3 months duration)
- Subjects with pain intensity of at least 5 on an 11-point NRS and requiring an equianalgesic dose range equivalent to 30 - 60 mg oral morphine per day
- Subjectsts taking = 325 mg acetylsalicylic acid (ASA) daily for cardiovascular prophylaxis who have been on a stable dose for = 30 days may be enrolled
- Males or non-pregnant, non-lactating, or postmenopausal females. Female patients of childbearing potential must use an acceptable method of contraception (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) during study period and have a negative urine pregnancy test (at screening).
- Expected course of the disease and the pain that will permit compliance with the study protocol over the entire study period
- The patient has been informed about the nature of the study, understood the information and given written informed consent before undergoing any study procedures
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Participation in another study parallel to or less than 30 days before study entry
- Alcohol and/or drug abuse in the investigator’s judgment, based on patient history and physical examination
- Positive urine test for drugs of abuse, other than prescription analgesic substances for a medical condition
- Subjects with respiratory depression in the absence of resuscitative equipment, and in patients with severely impaired respiratory centre/function, and in any patient who has or is suspected of having a paralytic ileus
- Subjects
who are opioid tolerant, or
have used opioids for any indication within 3 months of study start,
who have ever used opioids for longer than 6 months
- Previous and/or current unhealed extensive dermal damage in the area where the patch is to be applied (e.g., dermatitis, burns, scarring of the skin)
- Known hypersensitivity to any of the study medications, i.e., the active substance buprenorphine or to any of the excipients
- Any scheduled surgery and/or painful procedure during the course of the study
- History of seizure disorder, dementia and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin
- Intake of adjuvant analgesics (e.g. antidepressants, anticonvulsants, selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], muscle relaxants, bisphosphonates, corticosteroids, phytopharmaceutics), antiparkinsonian drugs, neuroleptics or laxatives if not on a stable dose within 30 days prior to the screening visit
- Concomitant intake and/or intake within 30 days prior to the screening visit of monoamine oxidase (MAO) inhibitors or anti-emetics
-TENS (transcutaneous electrical nerve stimulation), physiotherapy, acupuncture, and other adjunctive therapy if procedures are not stable, ie, performed at the same ferquency, within 30 days prior to the screening visit
- Patients suffering from myasthenia gravis

Study & Design

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