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Clinical Trials/EUCTR2013-000343-11-DK
EUCTR2013-000343-11-DK
Active, not recruiting
Phase 1

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

Clinical Research Centre, Hvidovre University Hospital0 sites40 target enrollmentApril 8, 2013
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ConditionsOral pain due to oral mucositis in patients undergoing a bone marrow transplantMedDRA version: 14.1Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 100000004856Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Oral pain due to oral mucositis in patients undergoing a bone marrow transplant
Sponsor
Clinical Research Centre, Hvidovre University Hospital
Enrollment
40
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 8, 2013
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Clinical Research Centre, Hvidovre University Hospital

Eligibility 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

  • •\- Known allergy towards bupivacaine or other local analgesia of the amide type
  • •\- Pregnancy
  • •\- Breastfeeding women

Outcomes

Primary Outcomes

Not specified

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