Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy

Diabetic Neuropathy, Painful Clinical Trial

Official title:

Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553475
• Other study ID #: A0081163
• Status: Completed
• Phase: Phase 3
• Start date: October 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Visual Analogue Scale (VAS) of pain is higher than 40 mm.
• Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

Exclusion Criteria:

• Malignancy within the past 2 years.
• Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Peripheral Nervous System Diseases

Intervention

Drug:
• placebo
Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
• pregabalin
Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
• pregabalin
Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Arakawa	Tokyo
Japan	Pfizer Investigational Site	Beppu	Oita
Japan	Pfizer Investigational Site	Bunkyo-ku	Tokyo
Japan	Pfizer Investigational Site	Chikushino	Fukuoka
Japan	Pfizer Investigational Site	Chitose	Hokkaido
Japan	Pfizer Investigational Site	Chiyoda-ku	Tokyo
Japan	Pfizer Investigational Site	Chuo-ku	Tokyo
Japan	Pfizer Investigational Site	Date-shi	Fukushima
Japan	Pfizer Investigational Site	Ebetu	Hokkaido
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Higashiosaka	Osaka
Japan	Pfizer Investigational Site	Hirano-ku	Osaka
Japan	Pfizer Investigational Site	Inashiki	Ibaraki
Japan	Pfizer Investigational Site	Kamakura	Kanagawa
Japan	Pfizer Investigational Site	Kasuga	Fukuoka
Japan	Pfizer Investigational Site	Kishiwada	Osaka
Japan	Pfizer Investigational Site	Kobe	Hyogo
Japan	Pfizer Investigational Site	Kumamoto
Japan	Pfizer Investigational Site	Kure	Hiroshima
Japan	Pfizer Investigational Site	Matsumoto	Nagano
Japan	Pfizer Investigational Site	Minato-ku	Tokyo
Japan	Pfizer Investigational Site	Nagasaki
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Naha	Okinawa
Japan	Pfizer Investigational Site	Nihonmatsu	Fukushima
Japan	Pfizer Investigational Site	Niigata
Japan	Pfizer Investigational Site	Nishitokyo	Tokyo
Japan	Pfizer Investigational Site	Ohta-ku	Tokyo
Japan	Pfizer Investigational Site	Oita
Japan	Pfizer Investigational Site	Okayama
Japan	Pfizer Investigational Site	Oyama-shi	Tochigi
Japan	Pfizer Investigational Site	Saga
Japan	Pfizer Investigational Site	Saitama
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sapporo	Hokkaiido
Japan	Pfizer Investigational Site	Sendai	Miyagi
Japan	Pfizer Investigational Site	Shibuya-ku	Tokyo
Japan	Pfizer Investigational Site	Shirakawa-shi	Fukushima
Japan	Pfizer Investigational Site	Sukagawa	Fukushima
Japan	Pfizer Investigational Site	Suminoe-ku	Osaka
Japan	Pfizer Investigational Site	Sunto-gun	Shizuoka
Japan	Pfizer Investigational Site	Tokushima
Japan	Pfizer Investigational Site	Tomishiro	Okinawa
Japan	Pfizer Investigational Site	Ueda	Nagano
Japan	Pfizer Investigational Site	Urazoe	Okinawa
Japan	Pfizer Investigational Site	Utsunomiya	Tochigi
Japan	Pfizer Investigational Site	Yamada	Okayama
Japan	Pfizer Investigational Site	Yatsushiro	Kumamoto
Japan	Pfizer Investigational Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Study Endpoint in Mean Weekly Pain Scores	Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Primary	Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations	Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Primary	Number of Responders	A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Primary	Change From Baseline at Week 1 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.; Change from baseline: Score at Week 1 minus score at baseline	From baseline to Week 1
Primary	Change From Baseline at Week 2 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.; Change from baseline: Score at Week 2 minus score at baseline	From baseline to Week 2
Primary	Change From Baseline at Week 3 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.; Change from baseline: Score at Week 3 minus score at baseline	From baseline to Week 3
Primary	Change From Baseline at Week 4 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.; Change from baseline: Score at Week 4 minus score at baseline	From baseline to Week 4
Primary	Change From Baseline at Week 5 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.; Change from baseline: Score at Week 5 minus score at baseline	From baseline to Week 5
Primary	Change From Baseline at Week 6 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.; Change from baseline: Score at Week 6 minus score at baseline	From baseline to Week 6
Primary	Change From Baseline at Week 7 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.; Change from baseline: Score at Week 7 minus score at baseline	From baseline to Week 7
Primary	Change From Baseline at Week 8 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.; Change from baseline: Score at Week 8 minus score at baseline	From baseline to Week 8
Primary	Change From Baseline at Week 9 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.; Change from baseline: Score at Week 9 minus score at baseline	From baseline to Week 9
Primary	Change From Baseline at Week 10 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.; Change from baseline: Score at Week 10 minus score at baseline	From baseline to Week 10
Primary	Change From Baseline at Week 11 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.; Change from baseline: Score at Week 11 minus score at baseline	From baseline to Week 11
Primary	Change From Baseline at Week 12 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.; Change from baseline: Score at Week 12 minus score at baseline	From baseline to Week 12
Primary	Change From Baseline at Week 13 in Mean Weekly Pain Scores	The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.; Change from baseline: Score at Week 13 minus score at baseline	From baseline to Week 13
Secondary	Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning	The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical	The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain	The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception	The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning	The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional	The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality	The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health	The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Mean Sleep Interference Scores	The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores	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.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
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.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores	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.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores	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.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores	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.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance	The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring	The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache	The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep	The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy	The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence	The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index	The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.	From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Secondary	Clinical Global Impression of Change	Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).	Week 13 or up to discontinuation
Secondary	Patient Global Impression of Change	The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).	Week 13 or up to discontinuation

External Links

•   To obtain contact information for a study center near you, click here.