Phase 2
Completed N=135
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)
Diabetic Neuropathy, Painful
Source: ClinicalTrials.gov NCT02215252 ↗
Enrolled (actual)
135
Serious AEs
1.5%
Results posted
May 2017
Primary outcomePrimary: Daily Pain Numeric Rating Scale (NRS) — 6.17; 6.62; 6.35; 5.45 Unit on a scale
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Pain Numeric Rating Scale (NRS) |
6.17; 6.62; 6.35; 5.45; 5.87; 6.07 | — |
| SECONDARY Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score |
9.09; 15.22; 4.44; 22.73; 31.11; 9.09 | — |
| SECONDARY Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score |
0; 4.35; 4.44; 11.36; 15.56; 2.27 | — |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain |
4.6; 5.3; 4.8; 3.7; 4.3; 4.2 | — |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain |
3.8; 4.9; 4.5; 3.3; 4.4; 4.2 | — |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain |
4.5; 5.8; 5.6; 4.1; 4.7; 4.9 | — |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain |
2.7; 5.0; 4.2; 2.0; 4.0; 3.5 | — |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia |
5.7; 6.1; 6.6; 4.8; 5.3; 5.9 | — |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) - Total Score |
40.6; 53.4; 50.7; 34.2; 44.6; 44.7 | — |
| SECONDARY Patient's Global Impression of Change Score (PGIC). |
20; 11; 16; 27; 30; 26 | — |
| SECONDARY Daily Sleep Interference Scale Score (DSIS). |
4.7; 5.6; 4.9; 4.1; 4.7; 4.7 | — |
| SECONDARY Total Amount of Rescue Medication Per Week |
2726; 3398; 1863; 2272; 2897; 1694 | — |
| SECONDARY Number of Days Participants Take Rescue Medication |
2.8; 2.1; 1.6; 2.3; 1.8; 1.5 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs) |
16; 24; 17; 1; 1; 0 | — |
| SECONDARY Number of Participants With Laboratory Test Values of Potential Clinical Importance |
38; 35; 37 | — |
| SECONDARY Fasted Total Cholesterol Values |
3.46; -1.45; -0.43; 6.59; -0.11; -1.71 | — |
| SECONDARY Fasted Low Density Lipoprotein (LDL) Cholesterol |
8.17; -1.73; 0.81; 13.61; 0.85; 1.48 | — |
| SECONDARY Plasma Concentration of PF-05089771 |
NA; 7673; 8784 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02215252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.