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Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

This study is currently recruiting participants.
Verified January 2013 by Danish University of Pharmaceutical Sciences
Sponsor:
Collaborator:
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00357942
First received: July 27, 2006
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

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: July 2014
Estimated Primary Completion Date: July 2014 (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
Copenhagen University Hospital, 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: Bettina Nygaard Nielsen, M.Sc. Pharm, sponsor contact person, 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: January 10, 2013
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 May 19, 2013