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ketamine/amitriptyline NP-H cream for Pain
Phase 3
Waitlist Available
Research Sponsored by Gary Morrow
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6 - baseline
Awards & highlights
Approved for 20 Other Conditions
Pivotal Trial
Summary
RATIONALE: Topical cream containing amitriptyline and ketamine may help relieve pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether topical amitriptyline and ketamine cream is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying the side effects and how well topical amitriptyline and ketamine cream work compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
Eligible Conditions
- Solid Tumors
- Nerve Damage
- Neurotoxicity
- Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6 - baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6 - baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Average Daily Peripheral Neuropathy Intensity Score From Baseline to Week 6 in Patients Treated With Amitriptyline and Ketamine Hydrochloride vs Placebo
Side effects data
From 2013 Phase 3 trial • 462 Patients • NCT004714454%
Fatigue
3%
Hyperglycemia
3%
Neuropathy
3%
Myalgia
2%
Insomnia
2%
Hypertension
2%
Dry Skin
2%
Allergic Rhinitis
2%
Burning Sensation
2%
Rash - Lower Extremities
2%
Cough
2%
Restless Leg Syndrome
2%
Pain Lower Extremities
2%
Pain in Joint
2%
Headache
2%
Pain in Knee
2%
Pain in Head / Neck
1%
Rash - NOS
1%
Vomiting
1%
Anorexia
1%
Tinnitus
1%
Edema - Upper Extremities
1%
Dehydration
1%
Dizziness
1%
Fever
1%
Feeling of Tightness / Flusing in Feet
1%
Liver enzymes
1%
Infection - Herpes Zoster
1%
Increased Heart Rate
1%
Hypothyroidism
1%
Anemia
1%
Rosacea
1%
Urinary Tract Infection
1%
Nausea
1%
Bronchitis
1%
Cramps
1%
Abdominal Pain
1%
Diarrhea
1%
Dyspepsia
1%
Migraine
1%
GERD
1%
Dyspnea
1%
Pain Upper Extremities
1%
Pain in Bone
1%
Pain in Back
100%
80%
60%
40%
20%
0%
Study treatment Arm
Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr
Placebo Cream
Awards & Highlights
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ketamine/amitriptyline NP-H creamExperimental Treatment1 Intervention
Patients apply 4 grams amitriptyline (4%) and ketamine (2%) hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
Group II: Placebo CreamPlacebo Group1 Intervention
Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epicept NP-1
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Gary MorrowLead Sponsor
15 Previous Clinical Trials
5,775 Total Patients Enrolled
2 Trials studying Pain
701 Patients Enrolled for Pain
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,677 Total Patients Enrolled
98 Trials studying Pain
17,200 Patients Enrolled for Pain
Supriya Mohile, MDStudy ChairJames P. Wilmot Cancer Center
1 Previous Clinical Trials
80 Total Patients Enrolled
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