Phase 2 N=180 Randomized Double-blind Treatment

Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy

Painful Diabetic Neuropathy

Bottom Line

View on ClinicalTrials.gov: NCT00695565 ↗

Enrolled (actual)

180

Serious AEs

3.3%

Results posted

Nov 2016

Primary outcome: Primary: Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation — -1.9; -2.4; -1.5; -2.7 units on a scale — p=0.168

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo Gel (Drug); Clonidine Topical Gel (ARC-4558) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Arcion Therapeutics Inc
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 12 in the Average Daily Pain NPRS (Numeric Pain Rating Scale) Score; mLOCF Imputation	-1.9; -2.4; -1.5; -2.7	0.168
SECONDARY Change From Baseline in Average Daily Pain NPRS Score for Each Week of Treatment; mLOCF Imputation	-0.6; -0.7; -1.0; -1.0; -1.2; -1.5	—
SECONDARY Change From Baseline to Week 12 in the Worst Daily Pain NPRS Score; mLOCF Imputation	-2.1; -2.5	—
SECONDARY Percentage of Subjects Who Experience at Least 30% Reduction in Average Daily Pain From Baseline; mLOCF Imputation	47; 52	—
SECONDARY Percentage of Subjects Who Experience at Least 50% Reduction in Average Daily Pain From Baseline; mLOCF Imputation	32; 37	—
SECONDARY Change From Baseline in the Brief Pain Inventory (BPI) Severity Scale at Week 12; mLOCF Imputation	-7.9; -9.6	—
SECONDARY Change From Baseline in the Brief Pain Inventory Functional Interference Scale at Week 12; mLOCF Imputation	-15.1; -17.3	—
SECONDARY Change From Baseline to Week 12 in Overall Quality of Sleep (Chronic Pain Sleep Inventory)	17.7; 19.2	—
SECONDARY Change From Baseline to Week 12 in the Depression Score of the Hospital Anxiety and Depression Scale (HADS)	-0.4; -0.9	—
SECONDARY Change From Baseline to Week 12 in the Anxiety Score of the Hospital Anxiety and Depression Scale (HADS)	-0.6; -1.1	—
SECONDARY Change From Baseline to Week 12 in the McGill Pain Questionnaire (Short Form) Total Score	-7.3; -8.7	—
SECONDARY Patient Global Impression of Change (PGIC) at Week 12	11.8; 21.2; 32.9; 27.1; 31.8; 28.2	—
SECONDARY Clinician Global Impression of Change (CGIC) at Week 12	5.8; 16.5; 38.4; 30.6; 27.9; 24.7	—
SECONDARY Change in Blood Pressure From Baseline to Week 12	-0.4; 1.0; -0.2; 1.0	—

Summary

The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.

Eligibility Criteria

Inclusion Criteria

has Type 1 or Type 2 diabetes mellitus
has a history of chronic pain attributable to a symmetrical stocking distribution neuropathy in the lower extremities for a duration of at least six months but less than or equal to five years prior to Screening

Exclusion Criteria

has neuropathy secondary to non-diabetic causes
has a significant neurological disorder or a condition that can cause symptoms that mimic peripheral neuropathy or might confound assessment of PDN
has other chronic pain with intensity at or greater than the bilateral pain in the feet/toes
is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain
is pregnant or lactating

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00695565). 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.