Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy.

NCT05029297 | Completed Phase 3 DMC

• 1 other identifier: ITHUEC-CAP/10-5
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical trial of "line extension" of drug ARAFARMADOL® 0.075% cream in a new formulation in topical solution applicable in roll-on and with the same therapeutic indications approved for the cream.

Conditions

Diabetic Neuropathy, Painful

Outcome Measures

Primary Outcomes (1)

• To demonstrate the efficacy and the non-inferiority of a new formulation of the capsaicin topical solution in "roll-on" compared to capsaicin in cream.

  To demonstrate the efficacy and the non-inferiority of a new formulation of Capsaicin 0.75 mg / g topical solution applicable in "roll-on" compared to the formulation currently marketed (comparator) in cream (Arafarmadol® 0.075% cream). The main variable will be the decrease in pain on the visual analogue pain scale (score range from 0 (no pain) to 10 (worst pain possible) at 8 weeks of treatment with each drug. The change in efficacy between the two treatments (pain reduction with cream minus pain reduction with roll-on) will be calculated and the 95% confidence interval for this change will be obtained; If the confidence interval does not exceed the non-inferiority limit (1.0), it will be concluded that the new formulation is not inferior to the one currently marketed.

  Baseline to 8 weeks

Secondary Outcomes (8)

• Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) between both treatment groups.

  From Visit 1, and at each visit, up to 22 weeks.

• Change from baseline in both treatment groups of QoL.

  Baseline to 8 weeks

• Treatment compliance in both treatment groups.

  At the end of each treatment phase (8th week).

• Change from baseline in both treatment groups of height.

  Baseline to every 4 weeks up to 22 weeks.

• Change from baseline in both treatment groups of weight.

  Baseline to every 4 weeks up to 22 weeks.

Study Arms (2)

CAPSAICIN 0.75 mg/g topical solution applicable in roll-on

EXPERIMENTAL

CAPSAICIN 0.75 mg / g topical solution applicable in roll-on: 4 applications per day for 8 weeks.

Drug: Capsaicin

CAPSAICIN 0.075% cream

ACTIVE COMPARATOR

CAPSAICIN 0.075% cream (ARAFARMADOL® 0.075% cream): 4 applications per day for 8 weeks.

Drug: Capsaicin

Interventions

Capsaicin DRUG

CAPSAICIN 0.075% cream; CAPSAICIN 0.75 mg/g topical solution applicable in roll-on

Eligibility Criteria

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

You may qualify if:

• Written or oral informed consent with witnesses, before initiating the specific procedures of the protocol.
• Non-pregnant, non-lactating man or woman ≥ 18 years.
• Patients diagnosed with Type I or II Diabetes Mellitus, treated or untreated.
• Patients with a diagnosis of painful peripheral diabetic neuropathy, treated or not treated
• Painful diabetic neuropathy of at least 3 months of evolution with moderate to severe pain ≥ 4 on the VAS scale in the selection phase.
• The pain must have been experienced daily, interfered with daily activities or sleep, and not attributable to psychological origin.
• Stabilization of pain medication at least during the month prior to the start of treatment. The patient must be prepared to remain in treatment with the same pain medications at the same doses as previous to the start, during the study and in the follow-up phase (24 weeks).
• Intact, non-irritated and dry skin in the painful areas to be treated.
• Patients with the ability to collaborate in the trial.

You may not qualify if:

• Allergic reactions to capsaicin.
• Patients with neuropathic pain of an etiology other than diabetes.
• Patients with peripheral ischemic pain due to diabetic artery disease.
• Patients with unstable glycemic control (glycosylated Hb ≥ 10.5%).
• Amputation of any part of the lower limb.
• Surgery scheduled during the clinical trial.
• Mild painful diabetic neuropathy (\<4 VAS).
• Other serious pathologies:
• Documented congestive heart failure or systolic dysfunction (LVEF ≤ 50%).
• Previous history of myocardial infarction in the 6 months prior to enrollment.
• Uncontrolled hypertension (160/110 mmHg maximum).
• Uncontrolled high-risk arrhythmias.
• Significant neurological or psychiatric disorders, including psychotic disorders, dementia that prevent patients from understanding and giving informed consent.
• Active uncontrolled infection.
• Use other topical pain medications in painful areas.

Sponsors & Collaborators

• Arafarma Group, S.A.: lead
• Fundación Teófilo Hernando, Spain: collaborator

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Dr. Raffaelle Carraro

  Hospital Universitario La Princesa. Madrid. Investigator Site Coordinator.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will receive one of the two interventions (CAPSAICIN topical solution and cream) during the initial phase of the study of 8 weeks and receive the other intervention during the second phase of the study of 8 weeks. Both phases will be separated in a 4 week washout period.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: August 31, 2021
• Study Start: November 4, 2010
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: September 14, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share