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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00349024
Date of registration:	05/07/2006
Prospective Registration:	No
Primary sponsor:	Children's Cancer and Leukaemia Group
Public title:	Polyvinylpyrrolidone-Sodium Hyaluronate Gel in Reducing Pain From Oral Mucositis in Young Patients With Cancer
Scientific title:	Efficacy of Gelclair™ in Reducing the Pain of Oral Mucositis in Children and Young People With Cancer (SC 2005 07)
Date of first enrolment:	July 2005
Target sample size:	50
Recruitment status:	Active, not recruiting
URL:	http://clinicaltrials.gov/show/NCT00349024
Study type:	Interventional
Study design:	Masking: Open Label, Primary Purpose: Supportive Care
Phase:	N/A

Countries of recruitment
Ireland	United Kingdom

Contacts

Name:	Faith Gibson, MD
Address:
Telephone:
Email:
Affiliation:	Great Ormond Street Hospital for Children NHS Foundation Trust

Name:	Tim O.B. Eden, MB, BS, FRCPE, FRCP, FRCPCH, F
Address:
Telephone:
Email:
Affiliation:	Christie Hospital NHS Foundation Trust

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Diagnosis of cancer, including, but not limited to, the following:

- Acute lymphoblastic leukemia

- Acute myeloid leukemia

- Brain tumor

- Hodgkin's lymphoma

- Non-Hodgkin's lymphoma

- Sarcoma

- Wilms' tumor

- Neuroblastoma

- Meets 1 of the following criteria:

- Admitted to an in-patient unit after undergoing chemotherapy that is anticipated
to cause oral mucositis

- Admitted to an in-patient unit after undergoing myeloablative therapy followed
by peripheral blood stem cell or bone marrow transplantation

- Is experiencing oral pain due to mucositis

PATIENT CHARACTERISTICS:

- No known hypersensitivity to polyvinylpyrrolidone-sodium hyaluronate gel

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Concurrent analgesics allowed

Age minimum: 4 Years
Age maximum: 19 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Cancer

Sarcoma

Pain

Lymphoma

Mucositis

Brain and Central Nervous System Tumors

Unspecified Childhood Solid Tumor, Protocol Specific

Neuroblastoma

Chordoma

Leukemia

Intervention(s)

Drug: polyvinylpyrrolidone-sodium hyaluronate gel

Primary Outcome(s)

Duration of action of polyvinylpyrrolidone-sodium hyaluronate gel

Timing and intensity of oral pain

Acceptability, effectiveness, and adherence to regimens including polyvinylpyrrolidone-sodium hyaluronate gel

Symptoms, other than pain, considered important to the pediatric population

Secondary Outcome(s)

Secondary ID(s)

CCLG-SC-2005-07

CDR0000481526

EU-20621

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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