Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00553475
First received: November 2, 2007
Last updated: July 16, 2010
Last verified: July 2010
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Purpose
To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Neuropathy, Painful |
Drug: placebo Drug: pregabalin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change From Baseline to Study Endpoint in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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).
- Number of Responders [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.
- Change From Baseline at Week 1 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 1 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 2 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 2 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 3 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 3 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 4 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 4 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 5 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 5 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 6 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 6 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 7 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 7 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 8 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 8 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 9 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 9 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 10 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 10 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 11 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 11 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 12 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
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
- Change From Baseline at Week 13 in Mean Weekly Pain Scores [ Time Frame: From baseline to Week 13 ] [ Designated as safety issue: No ]
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
Secondary Outcome Measures:
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Mean Sleep Interference Scores [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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 [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index [ Time Frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint) ] [ Designated as safety issue: No ]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.
- Clinical Global Impression of Change [ Time Frame: Week 13 or up to discontinuation ] [ Designated as safety issue: No ]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).
- Patient Global Impression of Change [ Time Frame: Week 13 or up to discontinuation ] [ Designated as safety issue: No ]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).
| Enrollment: | 314 |
| Study Start Date: | October 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: placebo
Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
|
| Experimental: Pregabalin 300 mg/day |
Drug: pregabalin
Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
|
| Experimental: Pregabalin 600 mg/day |
Drug: pregabalin
Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553475
Show 49 Study Locations
Show 49 Study LocationsSponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trials Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00553475 History of Changes |
| Other Study ID Numbers: | A0081163 |
| Study First Received: | November 2, 2007 |
| Results First Received: | March 10, 2010 |
| Last Updated: | July 16, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Diabetic Neuropathies Peripheral Nervous System Diseases Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Neurotoxicity Syndromes Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Signs and Symptoms Poisoning Substance-Related Disorders Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 23, 2013