Trial Outcomes & Findings for Neuropathic Pain Syndrome Patient Study (MK-0000-072) (NCT NCT00570310)

Last Updated: 2015-05-07

Results Overview

Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

104 participants

Primary outcome timeframe

Baseline and 6 Weeks

Results posted on

2015-05-07

Participant Flow

Last Patient Entered: 06-Dec-07 Last Patient Last Visit: 11-Sep-08 \# Sites: 20 sites randomized at least 1 patient. 21 sites screened at least 1 patient

All patients were titrated up to the maximum tolerated dose of active treatment (pregabalin) over approximately 12 days. Patient were treated at the maximum tolerated dose until randomization at which time patient were either continued on active treatment or withdrawn from active treatment (i.e. placebo) in a double-blind fashion.

Participant milestones

Participant milestones
Measure	Pregabalin Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.	Placebo Patients were treated with placebo starting at randomization.
Overall Study STARTED	53	51
Overall Study COMPLETED	51	45
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.	Placebo Patients were treated with placebo starting at randomization.
Overall Study Adverse Event	1	2
Overall Study Lack of Efficacy	1	4

Baseline Characteristics

Neuropathic Pain Syndrome Patient Study (MK-0000-072)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin n=30 Participants Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.	Placebo n=32 Participants Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.	Total n=62 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 10.8 • n=5 Participants	59.3 years STANDARD_DEVIATION 11.0 • n=7 Participants	60.5 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Body Mass Index	32.6 kilograms/meter^2 n=5 Participants	31.3 kilograms/meter^2 n=7 Participants	31.9 kilograms/meter^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 Weeks

Population: Patients who had a ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.

Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)

Outcome measures

Outcome measures
Measure	Pregabalin n=30 Participants Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.	Placebo n=32 Participants Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
Daily Evening Patient Reported Pain Intensity Scores	0.14 Units on a Scale Interval -2.0 to 4.33	1.57 Units on a Scale Interval -1.83 to 8.0

SECONDARY outcome

Timeframe: 6 Weeks

Population: Primary Responders: ≥30% decrease in mean of average daily pain intensity during the last 3 days of the maintenance phase relative to baseline.

Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)

Outcome measures

Outcome measures
Measure	Pregabalin n=30 Participants Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.	Placebo n=32 Participants Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study	15.54 Days Interval 3.0 to 21.0	7.87 Days Interval 3.0 to 21.0

Adverse Events

Pregabalin

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pregabalin n=51 participants at risk Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.	Placebo n=53 participants at risk Patients were treated with placebo starting at randomization.
Cardiac disorders Arrhythmia	0.00% 0/51 • The reported AEs were collected after patients were randomized to the double-blind withdrawal period of the study. AEs that were collected prior to randomization are not reported in this document.	1.9% 1/53 • The reported AEs were collected after patients were randomized to the double-blind withdrawal period of the study. AEs that were collected prior to randomization are not reported in this document.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER