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

Sponsor:	Danish University of Pharmaceutical Sciences
Collaborator:	Rigshospitalet, Denmark
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	75
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: C group I Morphine mouthwash and placebo i.v.(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
Active Comparator: C group II Placebo mouthwash and morphine i.v.(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
Placebo Comparator: C group III Placebo mouthwash and placebo i.v. (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.

Sponsors and Collaborators

Danish University of Pharmaceutical Sciences

Rigshospitalet, Denmark

Investigators

Study Chair:

Bettina N Nielsen, PhD student M.Sc.Pharm

Faculty of Pharmaceutical Sciences, University of Copenhagen

More Information

No publications provided

Responsible Party:	MSc Pharm Bettina N. Nielsen, Danish University of Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT00357942 History of Changes
Other Study ID Numbers:	102010, 2006-003260-53
Study First Received:	July 27, 2006
Last Updated:	July 7, 2011
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Danish University of Pharmaceutical Sciences:

Morphine
Mouthwash
Mucositis
Pain

Cancer
Child
Adolescent

Additional relevant MeSH terms:

Stomatitis
Mucositis
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Analgesics
Morphine

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012