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

NCT00553475 | Completed Phase 3 Results

• 1 other identifier: A0081163
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 49

Brief 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.

Conditions

Diabetic Neuropathy, Painful

Outcome Measures

Primary Outcomes (16)

• 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)

• 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)

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (23)

• Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning

  From baseline to Week 13 or up to study discontinuation (Study Endpoint)

• Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical

  From baseline to Week 13 or up to study discontinuation (Study Endpoint)

• Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain

  From baseline to Week 13 or up to study discontinuation (Study Endpoint)

• Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception

  From baseline to Week 13 or up to study discontinuation (Study Endpoint)

• Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning

  From baseline to Week 13 or up to study discontinuation (Study Endpoint)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: placebo

Pregabalin 300 mg/day

EXPERIMENTAL

Drug: pregabalin

Pregabalin 600 mg/day

EXPERIMENTAL

Drug: pregabalin

Interventions

placebo DRUG

Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)

Placebo

pregabalin DRUG

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

Pregabalin 300 mg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (49)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

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Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

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Pfizer Investigational Site

Kasuga, Fukuoka, Japan

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Pfizer Investigational Site

Date-shi, Fukushima, Japan

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Pfizer Investigational Site

Nihommatsu, Fukushima, Japan

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Pfizer Investigational Site

Shirakawa-shi, Fukushima, Japan

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Pfizer Investigational Site

Sukagawa, Fukushima, Japan

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Pfizer Investigational Site

Kure, Hiroshima, Japan

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Pfizer Investigational Site

Chitose, Hokkaido, Japan

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Pfizer Investigational Site

Ebetu, Hokkaido, Japan

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Pfizer Investigational Site

Sapporo, Hokkaido, Japan

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Pfizer Investigational Site

Sapporo, Hokkaiido, Japan

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Pfizer Investigational Site

Kobe, Hyōgo, Japan

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Pfizer Investigational Site

Inashiki, Ibaraki, Japan

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Pfizer Investigational Site

Kamakura, Kanagawa, Japan

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Pfizer Investigational Site

Yokohama, Kanagawa, Japan

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Pfizer Investigational Site

Yatsushiro, Kumamoto, Japan

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Pfizer Investigational Site

Sendai, Miyagi, Japan

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Pfizer Investigational Site

Matsumoto, Nagano, Japan

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Pfizer Investigational Site

Ueda, Nagano, Japan

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Pfizer Investigational Site

Beppu, Oita Prefecture, Japan

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Pfizer Investigational Site

Yamada, Okayama-ken, Japan

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Pfizer Investigational Site

Naha, Okinawa, Japan

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Pfizer Investigational Site

Tomishiro, Okinawa, Japan

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Pfizer Investigational Site

Urazoe, Okinawa, Japan

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Pfizer Investigational Site

Higashiosaka, Osaka, Japan

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Pfizer Investigational Site

Hirano-ku, Osaka, Japan

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Pfizer Investigational Site

Kishiwada, Osaka, Japan

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Pfizer Investigational Site

Suminoe-ku, Osaka, Japan

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Pfizer Investigational Site

Sunto-gun, Shizuoka, Japan

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Pfizer Investigational Site

Oyama-shi, Tochigi, Japan

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Pfizer Investigational Site

Utsunomiya, Tochigi, Japan

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Pfizer Investigational Site

Arakawa City, Tokyo, Japan

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Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

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Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

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Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

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Pfizer Investigational Site

Minato-ku, Tokyo, Japan

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Pfizer Investigational Site

Nishitōkyō, Tokyo, Japan

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Pfizer Investigational Site

Ohta-ku, Tokyo, Japan

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Pfizer Investigational Site

Shibuya-ku, Tokyo, Japan

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Pfizer Investigational Site

Fukuoka, Japan

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Pfizer Investigational Site

Kumamoto, Japan

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Pfizer Investigational Site

Nagasaki, Japan

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Pfizer Investigational Site

Niigata, Japan

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Pfizer Investigational Site

Okayama, Japan

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Pfizer Investigational Site

Ōita, Japan

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Pfizer Investigational Site

Saga, Japan

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Pfizer Investigational Site

Saitama, Japan

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Pfizer Investigational Site

Tokushima, Japan

Location

Related Publications (5)

• Alexander J Jr, Edwards RA, Manca L, Grugni R, Bonfanti G, Emir B, Whalen E, Watt S, Brodsky M, Parsons B. Integrating Machine Learning With Microsimulation to Classify Hypothetical, Novel Patients for Predicting Pregabalin Treatment Response Based on Observational and Randomized Data in Patients With Painful Diabetic Peripheral Neuropathy. Pragmat Obs Res. 2019 Oct 31;10:67-76. doi: 10.2147/POR.S214412. eCollection 2019.

  PMID: 31802967 DERIVED

• Alexander J Jr, Edwards RA, Brodsky M, Manca L, Grugni R, Savoldelli A, Bonfanti G, Emir B, Whalen E, Watt S, Parsons B. Using time series analysis approaches for improved prediction of pain outcomes in subgroups of patients with painful diabetic peripheral neuropathy. PLoS One. 2018 Dec 6;13(12):e0207120. doi: 10.1371/journal.pone.0207120. eCollection 2018.

  PMID: 30521533 DERIVED

• Edwards RA, Bonfanti G, Grugni R, Manca L, Parsons B, Alexander J. Predicting Responses to Pregabalin for Painful Diabetic Peripheral Neuropathy Based on Trajectory-Focused Patient Profiles Derived from the First 4 Weeks of Treatment. Adv Ther. 2018 Oct;35(10):1585-1597. doi: 10.1007/s12325-018-0780-3. Epub 2018 Sep 11.

  PMID: 30206821 DERIVED

• Parsons B, Li C, Emir B, Vinik AI. The efficacy of pregabalin for treating pain associated with diabetic peripheral neuropathy in subjects with type 1 or type 2 diabetes mellitus. Curr Med Res Opin. 2018 Nov;34(11):2015-2022. doi: 10.1080/03007995.2018.1509304. Epub 2018 Sep 20.

  PMID: 30084288 DERIVED

• Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.

  PMID: 27611736 DERIVED

Related Links

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

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 25, 2021
• Results First Posted: June 22, 2010

Record last verified: 2010-07

Locations

JP (49)