Topical Morphine for Stomatitis-Related Pain Induced by Chemotherapy - Full Text View

Sponsors and Collaborators:	Danish University of Pharmaceutical Sciences Rigshospitalet, Denmark The University Hospital in Lund, Sweden
Information provided by:	Danish University of Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT00357942

Purpose

Stomatitis/oral mucositis is a common side effect to chemotherapy. Stomatitis is often associated with soreness and painful ulcers in the mouth. The study hypothesis is that morphine administrated as a mouthwash can relieve stomatitis-related pain by a local pain-relieving effect.

The purpose of this study is to test the pain-relieving 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.

Condition	Intervention	Phase
Pain Mucositis	Drug: morphine solution for injection Drug: Placebo Drug: morphine mouthwash	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children

Further study details as provided by Danish University of Pharmaceutical Sciences:

Primary Outcome Measures:

Use of supplemental analgesics [ Time Frame: 24 hours and 2 additional days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain score at rest [ Time Frame: 24 hours and 2 additional days ] [ Designated as safety issue: No ]
Pain score at activity (performance of oral hygiene) [ Time Frame: 24 hours and 2 additional days ] [ Designated as safety issue: No ]
Time to first dose of supplemental analgesics [ Time Frame: 24 hours and 2 additional days ] [ Designated as safety issue: No ]
Frequency and severity of side effects [ Time Frame: 24 hours and 2 additional days ] [ Designated as safety issue: Yes ]
Oral intake of food [ Time Frame: 24 hours and 2 additional days ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
C group I: Experimental Morphine mouthwash (3 days) and placebo i.v.(first 24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)	Drug: morphine mouthwash morphine mouthwash 2 mg/ml, 50 microg/kg bodyweight every 3 hour for 24 hours and placebo solution for injection Drug: Placebo Placebo solution for injection every 3 hour for 24 hours
C group II: Active Comparator Placebo mouthwash (3 days) and morphine i.v.(first 24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)	Drug: morphine solution for injection morphine solution for injection 2 mg/ml, 50 microg/kg bodyweight, every 3 hour for 24 hours and placebo mouthwash Drug: Placebo Placebo mouthwash
C group III: Placebo Comparator Placebo mouthwash (3 days) and placebo i.v. (first 24 hours) Added on standard analgesic treatment (paracetamol and patient controlled analgesia, morphine)	Drug: Placebo Placebo mouthwash Drug: Placebo Placebo solution for injection every 3 hour for 24 hours

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Allergic to the investigational medical product
Alcohol or drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357942

Contacts

Contact: Bettina N Nielsen, PhD student M.Sc.Pharm	0045 35336228	bnn@farma.ku.dk
Contact: Janne Roemsing, PhD	0045 35336239	jr@farma.ku.dk

Locations

Denmark
The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)	Recruiting
Copenhagen, Denmark, DK-2100
Principal Investigator: Kjeld Schmiegelow, Professor M.D.
Sub-Investigator: Steen W. Henneberg, M.D.
Sweden
Barn- och Ungdomssjukvård, Universitetssjukhuset i Lund	Not yet recruiting
Lund, Sweden, 221 85
Principal Investigator: Mariann Stenberg, MD

Sponsors and Collaborators

Danish University of Pharmaceutical Sciences

Rigshospitalet, Denmark

The University Hospital in Lund, Sweden

Investigators

Study Chair:

Bettina N Nielsen, PhD student M.Sc.Pharm

Faculty of Pharmaceutical Sciences, University of Copenhagen

More Information

Responsible Party:	Danish University of Pharmaceutical Sciences ( MSc Pharm Bettina N. Nielsen )
Study ID Numbers:	102010, 2006-003260-53
Study First Received:	July 27, 2006
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00357942
Health Authority:	Denmark: Danish Medicines Agency; Sweden: Medicinal Products Agency

Keywords provided by Danish University of Pharmaceutical Sciences:

Morphine
Mouthwash
Mucositis
Pain

Cancer
Child
Adolescent

Study placed in the following topic categories:

Mouth Diseases
Morphine
Digestive System Diseases
Stomatitis
Mucositis

Gastrointestinal Diseases
Pain
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009