Topical application of morphine for wound healing and analgesia in patients with painful oral lesions

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007011-85-DE

Enrollment

Registered

2010-01-29

Start date

2009-12-10

Completion date

Unknown

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive and/or ulcerative Oral Lichen Planus.

Interventions

Product Name: morphin Product Code: NA Pharmaceutical Form: Oral solution INN or Proposed INN: morphinehydrochloride Concentration unit: % percent Concentration type: up to Concentration number: 4- P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine the proportion of Oral Lichen Planus patients whose lesions are healed on day six in the treatment vs control group. ;Secondary Objective: (1)Pain scores (spontaneous and functional, i.e. while chewing and swallowing of a standardized portion of food , e.g. a cracker) during the 5 days of treatment, obtained using a “Pain Diary”and a once daily phone interview. (2)Multidimensional assessment of pain at the oral lesion using the ‘German Pain Questionnaire’ (DSF). (3)Presence and severity of central (nausea, vomiting, sedation) and local (burning, dry mouth) opioid-related side effects. (4)Dose and timing of the current, standard medication for treatment of pain ;Primary end point(s): 60% of patients treated with the highest dose of morphine hydrochloride will have their lesions healed by day 5 of treatment. The effect is dose dependent.	—

Measure

Time frame

Main Objective: Determine the proportion of Oral Lichen Planus patients whose lesions are healed on day six in the treatment vs control group. ;Secondary Objective: (1)Pain scores (spontaneous and functional, i.e. while chewing and swallowing of a standardized portion of food , e.g. a cracker) during the 5 days of treatment, obtained using a “Pain Diary”and a once daily phone interview. (2)Multidimensional assessment of pain at the oral lesion using the ‘German Pain Questionnaire’ (DSF). (3)Presence and severity of central (nausea, vomiting, sedation) and local (burning, dry mouth) opioid-related side effects. (4)Dose and timing of the current, standard medication for treatment of pain ;Primary end point(s): 60% of patients treated with the highest dose of morphine hydrochloride will have their lesions healed by day 5 of treatment. The effect is dose dependent.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026