0.075% Capsaicin Lotion for the Treatment of Painful Diabetic Neuropathy

NCT03113448 | Completed Phase 3 DMC

• 2 other identifiers: MTU-EC-IM-5-195/59TCTR20170407001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial

Conditions

Peripheral Diabetic Neuropathy

Keywords

capsaicin; neuropathic pain; diabetic neuropathy; topical lotion

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (0-100 mm.)

  scale

  20 week

Secondary Outcomes (2)

• Short-form McGill Pain Questionnaire(SF-MPQ)

  20 week

• Neuropathic Pain Scale (NPS)

  20 week

Study Arms (2)

0.075% Capsaicin Lotion

ACTIVE COMPARATOR

0.075% Capsaicin Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop

Drug: 0.075% Capsaicin Lotion; Drug: placebo

Placebo Lotion

PLACEBO COMPARATOR

Placebo Lotion is used for application at skin area involved with symptomatic neuropathic pain (both feet or/and hands), 3-4 times a day, everyday for 8 weeks then stop

Drug: 0.075% Capsaicin Lotion; Drug: placebo

Interventions

0.075% Capsaicin Lotion DRUG

To apply 3-4 times per day, every day until 8 weeks then stop

0.075% Capsaicin Lotion; Placebo Lotion

placebo DRUG

To apply 3-4 times per day, every day until 8 weeks then stop

0.075% Capsaicin Lotion; Placebo Lotion

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DM type 2 over 1 year
• Clinical presentation of peripheral sensory such as burning pain
• DN4 score from 4 points
• Good consciousness to tell their score with informed consent agreement
• No adding dosage of previous pain control medications at least 4 weeks
• HbA1C 6.5-9.0%

You may not qualify if:

• Improper application site of skin for topical drugs such as abrasion wound.
• Allergic history of Capsaicin
• No intention to join the study with any reasons
• Other previous medications used that effect to peripheral neuropathy such as Carboplatin, Cisplatin, Colchicine, Dapsone, Etoposide, Ethambutol, Indomethacin, Isoniazid, Lithium, Metronidazole, Phenytoin, Pyridoxine, Statins, Stavudine (d4T) or conditions worsening peripheral nerves following that poor nutrition, kidney failure, chronic alcoholism, vitamin deficiency, Hypothyroidism

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

Related Publications (1)

• Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

  PMID: 36729473 DERIVED

MeSH Terms

Conditions

Neuralgia; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Kongkiat Kulkantrakorn, Professor

  Thammasat University Hospital

  STUDY CHAIR

• Pasiri Sithinamsuwan

  Phramongkutklao College of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical research

Model Details: Randomized controlled trial, double blind

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: April 13, 2017
• Study Start: January 19, 2017
• Primary Completion: April 21, 2017
• Study Completion: January 31, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)