Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
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ClinicalTrials.gov Identifier: NCT01455415 |
Recruitment Status :
Completed
First Posted : October 20, 2011
Results First Posted : April 23, 2015
Last Update Posted : January 28, 2021
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Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Painful Diabetic Peripheral Neuropathy |
Interventions |
Drug: pregabalin Drug: placebo |
Enrollment | 306 |
Participant Flow
Recruitment Details | 501 participants were screened, of whom 197 were withdrawn before randomization. 304 were randomized, of whom 3 discontinued before being treated. Participants were randomized at 47 centers in 3 countries: US (43), Czech Republic (3), and Italy (1). 4 centers received study drug but did not randomize participants. |
Pre-assignment Details | Participants completed daily pain and sleep diary from Visit 1 (Screening) to Visit 9. Participants with a mean pain score ≥ 4 (moderate to severe pain) and those having completed ≥ 4 daily pain dairies over past 7 days and having a mean score of ≥ 4 at Visit 2 (Baseline) were randomized. |
Arm/Group Title | Pregabalin/Placebo | Placebo/Pregablin |
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Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit. | Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit. |
Period Title: Period 1 | ||
Started | 154 [1] | 147 [1] |
Completed | 135 | 123 |
Not Completed | 19 | 24 |
Reason Not Completed | ||
Adverse Event (AE) Related to Study Drug | 9 | 6 |
Lost To Follow-up Related to Study Drug | 3 | 3 |
Drug Error not Associated to AE | 0 | 1 |
AE Not Related to Study Drug | 2 | 6 |
Withdrawal by Subject | 4 | 5 |
Unspecified Reason | 1 | 1 |
Protocol Violation | 0 | 2 |
[1]
Started=Treated
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Period Title: Washout | ||
Started | 135 | 123 |
Completed | 127 | 116 |
Not Completed | 8 | 7 |
Reason Not Completed | ||
AE Related to Study Drug | 2 | 0 |
Lost to Follow-up | 1 | 0 |
Drug Error not Associated to AE | 2 | 1 |
AE Not Related to Study Drug | 2 | 3 |
Unspecified Reason | 1 | 2 |
Protocol Violation | 0 | 1 |
Period Title: Period 2 | ||
Started | 127 | 116 |
Completed | 114 | 106 |
Not Completed | 13 | 10 |
Reason Not Completed | ||
AE Related to Study Drug | 1 | 2 |
Lost to Follow-up | 2 | 1 |
AE Not Related to Study Drug | 2 | 1 |
Lack of Efficacy | 2 | 0 |
Withdrawal by Subject | 2 | 3 |
Unspecified Reason | 2 | 3 |
Protocol Violation | 2 | 0 |
Period Title: Follow-up | ||
Started | 114 | 106 |
Completed | 111 | 104 |
Not Completed | 3 | 2 |
Reason Not Completed | ||
AE Related to Study Drug | 0 | 1 |
Lack of Efficacy | 0 | 1 |
Withdrawal by Subject | 2 | 0 |
Unspecified Reason | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Pregabalin/Placebo | Placebo/Pregablin | Total | |
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Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit. | Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit. | Total of all reporting groups | |
Overall Number of Baseline Participants | 154 | 147 | 301 | |
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Intent-to-Treat Population (ITT) included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 154 participants | 147 participants | 301 participants | |
59.4 (9.8) | 58.4 (9.5) | 58.9 (9.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 154 participants | 147 participants | 301 participants | |
Female |
65 42.2%
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72 49.0%
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137 45.5%
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Male |
89 57.8%
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75 51.0%
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164 54.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) |
ClinicalTrials.gov Identifier: | NCT01455415 |
Other Study ID Numbers: |
A0081268 2011-002743-10 ( EudraCT Number ) |
First Submitted: | October 17, 2011 |
First Posted: | October 20, 2011 |
Results First Submitted: | October 30, 2014 |
Results First Posted: | April 23, 2015 |
Last Update Posted: | January 28, 2021 |