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Topical Morphine for Stomatitis-related Pain Induced by Chemotherapy

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ClinicalTrials.gov Identifier: NCT00357942
Recruitment Status : Completed
First Posted : July 28, 2006
Last Update Posted : February 21, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Pain Mucositis Drug: morphine solution for injection Drug: Placebo Drug: morphine mouthwash Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Administration of Morphine: An Evaluation of the Analgesic Effect at Stomatitis in Children
Study Start Date : September 2006
Primary Completion Date : December 2013
Study Completion Date : January 2014

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Use of supplemental analgesics [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Pain score at rest [ Time Frame: 24 hours ]
  2. Pain score at activity (performance of oral hygiene) [ Time Frame: 24 hours ]
  3. Time to first dose of supplemental analgesics [ Time Frame: 24 hours ]
  4. Frequency and severity of side effects [ Time Frame: 24 hours ]
  5. Oral intake of food [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357942


Locations
Denmark
The Juliane Marie Center, Copenhagen University Hospital (Rigshospitalet)
Copenhagen, Denmark, DK-2100
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

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
2006-003260-53 ( EudraCT Number )
First Posted: July 28, 2006    Key Record Dates
Last Update Posted: February 21, 2014
Last Verified: February 2014

Keywords provided by Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences:
Morphine
Mouthwash
Mucositis
Pain
Cancer
Child
Adolescent

Additional relevant MeSH terms:
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Morphine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents