Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080873
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2004-04-07
Brief Title:
Traumeel S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Clinical Trial to Assess the Efficacy of Traumeel S IND66649 for the Prevention and Treatment of Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Traumeel S a mouth rinse may be effective in preventing or decreasing the severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem cell transplantation
PURPOSE This randomized clinical trial is studying how well Traumeel S works in preventing or treating mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation
PURPOSE This randomized clinical trial is studying how well Traumeel S works in preventing or treating mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation
Detailed Description:
OBJECTIVES
Compare the efficacy of Traumeel S vs placebo in reducing the severity and duration of chemotherapy-induced with or without total body irradiation mucositis in pediatric patients undergoing hematopoietic stem cell transplantation
Determine the safety of this drug in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to treatment with total body irradiation during conditioning chemotherapy yes vs no type of transplantation autologous vs allogeneic and participating institution COG vs foreign Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral Traumeel S mouth rinse 5 times daily beginning on day -1 before transplantation
Arm II Patients receive oral placebo mouth rinse 5 times daily beginning on day -1 before transplantation
In both arms treatment continues until day 20 post-transplantation OR until mucositis resolves to Walsh score 1 for 2 consecutive days
Patients are followed until day 100 post-transplantation
PROJECTED ACCRUAL A total of 180 patients 90 per treatment arm will be accrued for this study within 2 years
Compare the efficacy of Traumeel S vs placebo in reducing the severity and duration of chemotherapy-induced with or without total body irradiation mucositis in pediatric patients undergoing hematopoietic stem cell transplantation
Determine the safety of this drug in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to treatment with total body irradiation during conditioning chemotherapy yes vs no type of transplantation autologous vs allogeneic and participating institution COG vs foreign Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral Traumeel S mouth rinse 5 times daily beginning on day -1 before transplantation
Arm II Patients receive oral placebo mouth rinse 5 times daily beginning on day -1 before transplantation
In both arms treatment continues until day 20 post-transplantation OR until mucositis resolves to Walsh score 1 for 2 consecutive days
Patients are followed until day 100 post-transplantation
PROJECTED ACCRUAL A total of 180 patients 90 per treatment arm will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COG-ACCL0331 | OTHER | Childrens Oncology Group | None |
| CDR0000356179 | OTHER | None | None |