Phase 2
Completed N=138
The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy
Painful Diabetic Neuropathy · diabetic neuropathy · neuropathy
Source: ClinicalTrials.gov NCT02643251 ↗
Enrolled (actual)
138
Serious AEs
5.8%
Results posted
Aug 2017
Primary outcomePrimary: Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score — -1.2; -1.4 units on a scale — p=0.3361
Summary
The study will include three (3) phases: Screening Phase, Treatment Phase, and Follow-up Phase. Subjects who qualify to participate will apply study drug to their feet three times daily and will record their daily pain scores using an interactive voice response system (IVRS) during the Treatment Phase for 12 weeks. Approximately 100 adult subjects will be randomized to receive Clonidine Gel or Clonidine Gel Comparator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score |
-1.2; -1.4 | 0.3361 |
| SECONDARY Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores |
-1.29; -1.48 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is fluent in English and has provided written informed consent.
- Subject is an outpatient ≥18 years of age at the time of the Screening Visit.
- Subject has Type 1 or Type 2 diabetes mellitus with a hemoglobin A1C value 3.0 times the upper limit of normal or total bilirubin concentrations >2.0 times the upper limit of normal at the Screening Visit.
- Subject has received an investigational drug within 30 days prior to the Screening Visit.
- Subject has been treated previously with clonidine topical gel or participated in a clonidine topical gel clinical study, including Study CLO 290.
- Subject is currently taking or has taken clonidine (any formulation) over the past 4 weeks.
- Subject has known hypersensitivity or intolerance to clonidine.
- Subject is receiving or has received ≤7 days prior to the start of the Screening Phase "alternative medicine" products or treatments (e.g., acupuncture, naturopathy, homeopathy, etc.) for management of pain.
- Subject has a history of malignancy within the past 5 years except for successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
- Subject is planning to have surgery during the course of the study.
- Subject has significant skin changes on physical examination associated with either pedal edema or venous stasis disease.
- Subject has any dermatologic condition of the lower extremities that could affect study drug absorption
- Subject has current symptoms of depression with a Beck Depression Inventory II (BDI II) score >19 at the Screening Visit.
Data sourced from ClinicalTrials.gov (NCT02643251). 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.