Trial Outcomes & Findings for D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain (NCT NCT00301080)
NCT ID: NCT00301080
Last Updated: 2013-12-02
Results Overview
Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.
TERMINATED
PHASE3
7 participants
From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
2013-12-02
Participant Flow
Opened in 02/2006 (2-arm design with a 4 week treatment period). The 1st patient enrolled in 05/2006; 7 patients enrolled before it was suspended in 04/2007 pending revision (new 3-arm design \& 12 week treatment period). Re-opened in 09/2007, but drug manufacturing \& funding issues forced it to terminate with no further accrual in 05/2008.
Participant milestones
| Measure |
D-cycloserine 250mg
This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
|
Placebo (Original Version)
Placebo administered orally at a dose of twice per day for 4 weeks.
|
D-cycloserine 200mg
D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
|
D-cycloserine 50 mg
D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
|
Placebo (Revised Version)
Placebo administered orally at a dose of twice per day for 12 weeks.
|
|---|---|---|---|---|---|
|
Original Version (2 Arms & 4 Weeks)
STARTED
|
4
|
3
|
0
|
0
|
0
|
|
Original Version (2 Arms & 4 Weeks)
Received an Intervention
|
3
|
3
|
0
|
0
|
0
|
|
Original Version (2 Arms & 4 Weeks)
Completed 4 Week Intervention
|
3
|
3
|
0
|
0
|
0
|
|
Original Version (2 Arms & 4 Weeks)
COMPLETED
|
3
|
3
|
0
|
0
|
0
|
|
Original Version (2 Arms & 4 Weeks)
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
Revised Version (3 Arms & 12 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
0
|
|
Revised Version (3 Arms & 12 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Revised Version (3 Arms & 12 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
D-cycloserine 250mg
This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
|
Placebo (Original Version)
Placebo administered orally at a dose of twice per day for 4 weeks.
|
D-cycloserine 200mg
D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
|
D-cycloserine 50 mg
D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
|
Placebo (Revised Version)
Placebo administered orally at a dose of twice per day for 12 weeks.
|
|---|---|---|---|---|---|
|
Original Version (2 Arms & 4 Weeks)
Never received drug
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
Baseline characteristics by cohort
| Measure |
All Participants (Original Version)
n=7 Participants
All 7 patients enrolled were during the original version of the study design (2 arms: d-cycloserine 250mg vs. placebo - twice daily for 4 weeks). Since the study went on to change design and then terminate prior to completing accrual, it is not useful to report baseline measures by the original arms/groups.
|
|---|---|
|
Age, Customized
40-50 years
|
1 participants
n=5 Participants
|
|
Age, Customized
51-60 years
|
2 participants
n=5 Participants
|
|
Age, Customized
61-70 years
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)Population: No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)Population: No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Compare individual patients' self-reported pain relief scores before and after the treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)Population: No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Compare changes in neuropathic pain scores within each arm, as well as between the 3 arms of the study. Neuropathic pain will be assessed using 3 tools: the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)Population: No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)Population: No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Record the amount of opioid medication used by patients in each arm before and after the study treatment period.
Outcome measures
Outcome data not reported
Adverse Events
Placebo (Original Version)
D-cycloserine 250mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place