Topical application of morphine for wound healing and analgesia in patients with painful oral lesions
- Conditions
- Erosive and/or ulcerative Oral Lichen Planus.
- Registration Number
- EUCTR2007-007011-85-DE
- Lead Sponsor
- Charite Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
• American Society of Anesthesiologists (ASA) classification I-II (healthy or minimal systemic disease requiring no treatment)
• Ages of 18 75
• Providing written consent
• Either sex
• Able to self-asses and report their pain level
• OLP diagnosis is verified histologically
• Treated or not with Volon A in the past; at time of initiation of study they will not be taking Volon A.
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) no
F.1.3.1 Number of subjects for this age range
• Alcohol abuse or addiction – current
• Opioids and benzodiazepines abuse – life time
• Known hypersensitivity to morphine
• Pregnancy and lactation
• Major renal, hepatic, cardiac dysfunction
• Sleep-apnoea-syndrome
• Diabetes
• Participation in other clinical studies
• Institutionalized for any reason
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method