Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301080
Status:
TERMINATED
Last Update Posted:
2013-12-02
First Post:
2006-03-08
Brief Title:
D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding for the study fell through
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy It is not yet known whether D-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy
This randomized double-blind placebo-controlled clinical trial was designed to study D-cycloserine at 2 different doses to see how well each works compared to the other and to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy
This randomized double-blind placebo-controlled clinical trial was designed to study D-cycloserine at 2 different doses to see how well each works compared to the other and to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy
Detailed Description:
This is a randomized double-blind placebo-controlled study Initially patients were randomized to 1 of 2 treatment arms D-cycloserine 250 mg twice daily or placebo twice daily and treated for up to 4 weeks in the absence of unacceptable toxicity
Later the design was changed to randomize patients to 1 of 3 arms as follows
D-cycloserine 50 mg twice daily for up to 12 weeks
D-cycloserine 200 mg twice daily for up to 12 weeks
Placebo twice daily for up to 12 weeks
Later the design was changed to randomize patients to 1 of 3 arms as follows
D-cycloserine 50 mg twice daily for up to 12 weeks
D-cycloserine 200 mg twice daily for up to 12 weeks
Placebo twice daily for up to 12 weeks
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 |
|---|---|---|---|
| 504-038 | OTHER | Northwestern University IRB | None |