A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)
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| ClinicalTrials.gov Identifier: NCT02215252 |
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Recruitment Status :
Completed
First Posted : August 13, 2014
Results First Posted : May 5, 2017
Last Update Posted : May 5, 2017
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Neuropathy, Painful | Drug: PF-05089771 150 mg Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg Drug: Pregabalin 300 mg Drug: PF-05089771 150 mg + Pregabalin 300 mg | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 141 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Double Blind Placebo And Active Controlled Parallel Group Phase 2 Study To Evaluate PF-05089771 As A Monotherapy And As An Add-on To Pregabalin For The Treatment Of Painful Diabetic Peripheral Neuropathy |
| Actual Study Start Date : | November 10, 2014 |
| Actual Primary Completion Date : | July 15, 2015 |
| Actual Study Completion Date : | September 28, 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Peripheral Nerve Disorders
Drug Information available for:
Pregabalin
| Arm | Intervention/treatment |
|---|---|
| Experimental: PF-05089771 |
Drug: PF-05089771 150 mg
PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks. |
| Experimental: Placebo |
Drug: Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks. |
| Experimental: Pregabalin |
Drug: Pregabalin 300 mg
Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks. |
| Experimental: PF-05089771 + Pregabalin |
Drug: PF-05089771 150 mg + Pregabalin 300 mg
PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks. |
Primary Outcome Measures :
- Daily Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 1, Week 2, Week 3 and Week 4 ]The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.
Secondary Outcome Measures :
- Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score [ Time Frame: Baseline, Week 1, Week 2, Week 3 and Week 4 ]Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).
- Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score [ Time Frame: Baseline, Week 1, Week 2, Week 3, and Week 4 ]Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).
- Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain [ Time Frame: Baseline, Week 2, and Week 4 ]Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
- Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain [ Time Frame: Baseline, Week 2 and Week 4 ]Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
- Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain [ Time Frame: Baseline, Week 2, and Week 4 ]Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
- Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain [ Time Frame: Baseline, Week 2 and Week 4 ]Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
- Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia [ Time Frame: Baseline, Week 2 and Week 4 ]Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
- Neuropathic Pain Symptom Inventory (NPSI) - Total Score [ Time Frame: Baseline, Week 2 and Week 4 ]Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.
- Patient's Global Impression of Change Score (PGIC). [ Time Frame: Baseline, Week 2, and Week 4 ]Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, "Improved", "No Change" and "Worse".
- Daily Sleep Interference Scale Score (DSIS). [ Time Frame: Baseline, Week 1, Week 2, Week 3 and Week 4 ]Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.
- Total Amount of Rescue Medication Per Week [ Time Frame: Baseline, Week 1, Week 2, Week 3, and Week 4 ]Total amount of rescue medication participants take per week
- Number of Days Participants Take Rescue Medication [ Time Frame: Baseline, Week 1, Week 2, Week 3 and Week 4 ]Number of days participants take rescue medication per week.
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) [ Time Frame: Screening to Day 36, and Day 64 ]An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.
- Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Screening, Day 1, Day 15 and Day 29 ]The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.
- Fasted Total Cholesterol Values [ Time Frame: Baseline, Week 2 and Week 4 ]Percentage Change from Baseline in Fasted Total Cholesterol values
- Fasted Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Baseline, Week 2 and Week 4 ]Percentage Change from Baseline in LDL cholesterol Friedewald by PEG
- Plasma Concentration of PF-05089771 [ Time Frame: Baseline, Week 2 and Week 4 ]All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women aged 18 years to 80 years.
- Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization.
- Presence of ongoing pain due to DPN for at least 6 months.
- Willing to discontinue protocol-specified prohibited pain medications for DPN throughout the duration of the study.
Exclusion Criteria:
- Painful neuropathies or painful conditions other than DPN that may confound evaluation of pain due to DPN during the study.
- Subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy.
- Subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities.
- Pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215252
Locations
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Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT02215252 |
| Other Study ID Numbers: |
B3291026 DPN NAV1.7 ( Other Identifier: Alias Study Number ) |
| First Posted: | August 13, 2014 Key Record Dates |
| Results First Posted: | May 5, 2017 |
| Last Update Posted: | May 5, 2017 |
| Last Verified: | March 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases Diabetic Neuropathies Pain Neuromuscular Diseases Nervous System Diseases Neurologic Manifestations Diabetes Complications Diabetes Mellitus Endocrine System Diseases Pregabalin Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |