NCT00357942

Brief Summary

Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local analgesic effect. The purpose of this study is to test the analgesic effect of a morphine mouthwash versus morphine injections or placebo (no active drug) in children/adolescents with stomatitis related to chemotherapy. Besides the investigational drugs (morphine mouthwash and morphine injections) the children/adolescents receive a standardized analgesic treatment for stomatitis-related pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4 pain

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 21, 2014

Status Verified

February 1, 2014

Enrollment Period

7.3 years

First QC Date

July 27, 2006

Last Update Submit

February 20, 2014

Conditions

PainMucositis

Keywords

MorphineMouthwashMucositisPainCancerChildAdolescent

Outcome Measures

Primary Outcomes (1)

  • Use of supplemental analgesics

    24 hours

Secondary Outcomes (5)

  • Pain score at rest

    24 hours

  • Pain score at activity (performance of oral hygiene)

    24 hours

  • Time to first dose of supplemental analgesics

    24 hours

  • Frequency and severity of side effects

    24 hours

  • Oral intake of food

    24 hours

Study Arms (3)

C group I

EXPERIMENTAL

Morphine mouthwash and placebo i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Drug: morphine mouthwashDrug: Placebo

C group II

ACTIVE COMPARATOR

Placebo mouthwash and morphine i.v.(24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Drug: morphine solution for injectionDrug: Placebo

C group III

PLACEBO COMPARATOR

Placebo mouthwash and placebo i.v. (24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)

Drug: Placebo

Interventions

morphine solution for injectionDRUG

morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash

C group II
PlaceboDRUG

Placebo mouthwash

C group IIC group III
morphine mouthwashDRUG

morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection

C group I

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children and adolescents at The Juliane Marie Center at Copenhagen University Hospital (Rigshospitalet, Denmark) or at The University Hospital in Lund (Sweden)
  • Receiving chemotherapy in relation to a cancer disease
  • Pain score of minimum 3 (VAS-scale) at rest for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale) or a pain score of minimum 5 (VAS-scale) at activity for mouth pain in combination with stomatitis of minimum grade 1 (WHO-scale)
  • Negative pregnancy test, when relevant (judged by physician)
  • Patients and/or parents understand and speak danish (Denmark) / swedish (Sweden)
  • Signed informed consent

You may not qualify if:

  • Allergic to the investigational medical product
  • Alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)

Copenhagen, DK-2100, Denmark

Location

MeSH Terms

Conditions

PainMucositisNeoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Bettina N Nielsen, PhD student M.Sc.Pharm

    Faculty of Pharmaceutical Sciences, University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc. Pharm, sponsor contact person

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 28, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

February 21, 2014

Record last verified: 2014-02

Locations

DK(1)