A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00553280

Enrollment

123

Registered

2007-11-05

Start date

2008-02-29

Completion date

2010-01-31

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy, Painful

Brief summary

The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163

Interventions

DRUGpregabalin

Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A0081163. * Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study

Exclusion criteria

* Patients who experienced serious adverse events in the preceding study (A0081163) that were determined by the investigator or the study sponsor to be causally related to the study medication. * Patients exhibiting treatment non-compliance in the preceding study (A0081163)

Design outcomes

Primary

Measure	Time frame	Description
Summary of Adverse Events	53 weeks	Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.

Secondary

Measure	Time frame	Description
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores	From baseline to 52 weeks or study discontinuation (Study Endpoint)	The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.

Countries

Japan

Participant flow

Recruitment details

Thirty-six (36) centers in Japan

Pre-assignment details

Patients with pain associated with diabetic peripheral neuropathy who had completed the 13-week treatment phase in the preceding study (Study A0081163: NCT00553475), without any treatment-related serious adverse events or any compliance problems were eligible for the study.

Participants by arm

Arm	Count
Pregabalin Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 \< CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr \> 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.	123
Total	123

Arm

Count

Pregabalin

Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 \< CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr \> 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.

123

Total

123

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	19
Overall Study	Lack of Efficacy	3
Overall Study	Physician Decision	1
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	Pregabalin
Age, Customized 18 - 44 years	6 participants
Age, Customized < 18 years	0 participants
Age, Customized 45 - 64 years	71 participants
Age, Customized >= 65 years	46 participants
Age, Customized	61.7 years STANDARD_DEVIATION 10
Sex: Female, Male Female	23 Participants
Sex: Female, Male Male	100 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	101 / 123
serious Total, serious adverse events	21 / 123

Outcome results

Primary

Summary of Adverse Events

Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.

Time frame: 53 weeks

Population: Safety analysis set: all participants who had received at least one dose of the study drug.

Arm	Measure	Group	Value (NUMBER)
Pregabalin	Summary of Adverse Events	Participants with adverse events	114 participants
Pregabalin	Summary of Adverse Events	Participants with serious adverse events	21 participants
Pregabalin	Summary of Adverse Events	Participants with severe adverse events	7 participants
Pregabalin	Summary of Adverse Events	Participants discontinued due to adverse events	17 participants
Pregabalin	Summary of Adverse Events	Dose reduced or temporary discontinuation	43 participants

Secondary

Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores

The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.

Time frame: From baseline to 52 weeks or study discontinuation (Study Endpoint)