Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms

NCT02497066 | Completed Phase 3

• 1 other identifier: #412770-2
• Study Type: interventional
• Target: 399
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this protocol is to determine the effectiveness of using compounded topical pain creams for treating neuropathic, nociceptive, or mixed-pain syndromes. Since these compounded pain creams may be associated with burning or irritation at the application site, and possible systemic effects may present, the secondary objective is to determine the relative satisfaction with the creams. The investigators hypothesis is that the active pain creams may provide significant benefit compared to placebo cream. 3.1 Specific Aims

1. 1.Specific Aim 1 will determine pain relief following treatment with the appropriate (based on specified pain) compounded topical pain cream or a placebo cream. The investigators hypothesis is that the compounded topical pain creams will provide greater pain relief than placebo creams.
2. 2.Specific Aim 2 will measure the patient satisfaction with the cream (compound or placebo). The investigators hypothesis is that the compounded topical pain creams will improve patient satisfaction, while the placebo cream will not result in a change in patient satisfaction with their pain treatment.

Conditions

Pain

Keywords

topical; compound; pain

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale (NPRS) 0-10

  The Numerical Pain Rating Scale is a unidimensional measure of pain intensity. It is an 11 point numerical scale (with 0 meaning no pain; and 10 meaning the worst possible pain imaginable) used to assess pain intensity for persons able to self-report.

  1 month

Secondary Outcomes (6)

• Change in Health Status via Rand Corporation SF-36

  1 month

• 5-point Likert Satisfaction Scale (1-5)

  1 month

• Composite outcome determined by combining the subjects average change in pain score measured by the Numerical Pain Rating Scale and their score on the 5-point Likert Satisfaction Scale.

  1 month

• Numerical Pain Rating Scale (NPRS) 0-10

  3 months

• Change in Health Status via Rand Corporation SF-36

  3 Months

Study Arms (3)

Neuropathic Pain

PLACEBO COMPARATOR

Subjects with neuropathic pain will receive a neuropathic pain cream combined of Ketamine 10%/Gabapentin 6%/Clonidine 0.2% and Lidocaine 2% or placebo. They will be told to use the pain cream 3 times per day. Each will receive cream in identical dispensers. Cream is dispensed by rotating the base of the device and each rotation also produces a clicking sound. The number of clicks will be standardized so that all doctors utilize the same prescription depending on the size of the patient's pain location.

Other: Neuropathic pain cream

Nociceptive pain

PLACEBO COMPARATOR

Subjects with nociceptive pain will receive a nociceptive pain cream combined of Ketoprofen 10%/Baclofen 2%/Cyclobenzaprine 2% and Lidocaine 2% or placebo. They will be told to use the pain cream 3 times per day. Each will receive cream in identical dispensers. Cream is dispensed by rotating the base of the device and each rotation also produces a clicking sound. The number of clicks will be standardized so that all doctors utilize the same prescription depending on the size of the patient's pain location.

Other: Nociceptive pain cream

Mixed pain

PLACEBO COMPARATOR

Subjects who have a mixed (nociceptive and neuropathic) pain conditions will receive a mixed pain cream combined of Ketamine 10%/Gabapentin 6%/Diclofenac 3%/baclofen 2%/Cyclobenzaprine 2% and Lidocaine 2% or placebo. They will be told to use the pain cream 3 times per day. Each will receive cream in identical dispensers. Cream is dispensed by rotating the base of the device and each rotation also produces a clicking sound. The number of clicks will be standardized so that all doctors utilize the same prescription depending on the size of the patient's pain location.

Other: Mixed pain cream

Interventions

Neuropathic pain cream OTHER

Subjects will apply the cream to the painful area.

Neuropathic Pain

Nociceptive pain cream OTHER

Subjects will apply the cream to the painful area.

Nociceptive pain

Mixed pain cream OTHER

Subjects will apply the cream to the painful area.

Mixed pain

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18;-90
• A localized pain complaint to include: the back, neck, face, groin, buttocks, abdomen, chest, or up to two extremities
• Average pain score ≥ 4/10 over the past week;
• Pain duration \> 6 weeks
• DEERS eligibility.

You may not qualify if:

• Previous prescription for a compounded pain cream.
• Cannot read or understand English.
• Allergic reaction to Ketamine, Gabapentin, Diclofenac, Baclofen, Cyclobenzaprine, Ketoprofen, Clonidine or lidocaine.
• Pregnancy. Ruling out pregnancy will be done in accordance with our standard procedures, which is to obtain a urine HCG in any female of child-bearing age who may be pregnant prior to starting any new medications.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Related Publications (1)

• Brutcher RE, Kurihara C, Bicket MC, Moussavian-Yousefi P, Reece DE, Solomon LM, Griffith SR, Jamison DE, Cohen SP. Compounded Topical Pain Creams to Treat Localized Chronic Pain: A Randomized Controlled Trial. Ann Intern Med. 2019 Mar 5;170(5):309-318. doi: 10.7326/M18-2736. Epub 2019 Feb 5.

  PMID: 30716769 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert E Brutcher, PharmD,Ph.D.

  WRNMMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 14, 2015
• Study Start: August 5, 2015
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: May 28, 2019

Record last verified: 2018-10