Phase 3
N=258
A Long-term Study for the Treatment of Painful Diabetic Neuropathy
Diabetic Neuropathies
Bottom Line
View on ClinicalTrials.gov: NCT00641719 ↗Enrolled (actual)
258
Serious AEs
12.8%
Results posted
Mar 2011
Primary outcome: Primary: Number of Participants Who Experienced an Adverse Event (AE) — 11; 22; 126; 121 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Duloxetine hydrochloride (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
11; 22; 126; 121 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint. |
2.1; 2.1 | — |
| SECONDARY Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale |
-0.9; -1.0 | — |
| SECONDARY Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint |
2.4; 2.6; 1.3; 1.5; 1.8; 1.9 | — |
| SECONDARY Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores |
-2.2; -2.3; -1.6; -1.6; -2.1; -2.1 | — |
| SECONDARY Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint |
1.4; 1.4; 1.2; 1.3; 1.4; 1.3 | — |
| SECONDARY Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores |
-1.1; -1.3; -1.1; -1.0; -0.8; -1.0 | — |
| SECONDARY Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint |
6.3; 5.4 | — |
| SECONDARY Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score |
0.2; -0.7 | — |
Summary
The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.
Eligibility Criteria
Inclusion Criteria
- Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).
- Patients who desire to receive continued treatment with LY248686 from the preceding study.
- Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7.
- Patients who can provide written consent in person.
Exclusion Criteria
- Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
- Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
- Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.
Data sourced from ClinicalTrials.gov (NCT00641719). 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.