Clinical trial with lozenges as local anesthesia for bone marrow transplant patients with oral pain

Clinical trial with lozenges as local anesthesia for allogeneic bone marrow transplant patients with oral mucositis - OMBMT Lozenge

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000343-11-DK

Enrollment

Registered

2013-04-08

Start date

2013-05-10

Completion date

Unknown

Last updated

2016-08-22

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

Conditions

Oral pain due to oral mucositis in patients undergoing a bone marrow transplant MedDRA version: 14.1 Level: LLT Classification code 10028130 Term: Mucositis oral System Organ Class: 100000004856

Interventions

Product Name: Bupizenge Product Code: BUPI25 Pharmaceutical Form: Lozenge INN or Proposed INN: Bupivacaine Hydrochloride CAS Number: 2180-92-9 Current Sponsor code: BUPI25 Other descriptive name: BUPI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Scheduled for a bone marrow transplant - Age between 18 and 80 years old - Ability to speak, read and understand danish - Ability to give written and oral 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Known allergy towards bupivacaine or other local analgesia of the amide type - Pregnancy - Breastfeeding women

Design outcomes

Primary

Measure	Time frame
Main Objective: After administration of bupivacain lozenges the patients pain due to oral mucositis can be reduced, showed on a Visuel Analog Scale (VAS) 0-10, where as 0 = No pain and 10 = worst pain ever ;Secondary Objective: - Reduce the use of opioids administered by a Patient Controlles Analgesia (PCA) pump - Improve the patients nutrition messuerede by weight and food intake - Improve the patients quality og life messuerede by a questionnaire;Primary end point(s): VAS evaluation of oral pain when administration of the lozenge;Timepoint(s) of evaluation of this end point: Daily	—

Measure

Time frame

Main Objective: After administration of bupivacain lozenges the patients pain due to oral mucositis can be reduced, showed on a Visuel Analog Scale (VAS) 0-10, where as 0 = No pain and 10 = worst pain ever ;Secondary Objective: - Reduce the use of opioids administered by a Patient Controlles Analgesia (PCA) pump - Improve the patients nutrition messuerede by weight and food intake - Improve the patients quality og life messuerede by a questionnaire;Primary end point(s): VAS evaluation of oral pain when administration of the lozenge;Timepoint(s) of evaluation of this end point: Daily

—

Secondary

Measure	Time frame
Secondary end point(s): - Timepoint for administration of the lozenge - Number of lozenges administrated per day - Opioid use administrated from a "Patient controlled anesthesia" (PCA) pump - Number of failed attempt to get opioids from the PCA pump - Weightloss - Food intake ;Timepoint(s) of evaluation of this end point: Daily	—

Countries

Denmark

Contacts

Public ContactStine Mogensen

Clinical Research Centre, Hvidovre University Hospital

sugetablet@gmail.com+4538626077

Outcome results

None listed

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