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Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy.

Primary Purpose

Diabetic Neuropathy, Painful

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Capsaicin

About this trial

This is an interventional treatment trial for Diabetic Neuropathy, Painful

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
History or current problem of substance abuse.
Pregnant or lactating women. Women of childbearing potential should use effective contraception.
Participation in another clinical trial with any non-marketed investigational drug during the 90 days prior to inclusion.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

CAPSAICIN 0.075% cream

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

All AEs will be recorded, whether considered minor or serious, drug-related or not.

Change from baseline in both treatment groups of QoL.

The EQ-5D consists of 2 parts - the descriptive part and the visual scale analog (EVA). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, habitual activities, pain / discomfort, and anxiety / depression. In the EVA the patient scores their health between two extremes, 0 and 100, worst and best health status imaginable.

Treatment compliance in both treatment groups.

Treatment compliance is measured by the use of Morisky-Green test.

Change from baseline in both treatment groups of height.

Height measured by cm.

Change from baseline in both treatment groups of weight.

Weight measured by kg.

Change from baseline in both treatment groups of blood pressure.

Blood pressure measured by mm Hg.

Change from baseline in both treatment groups of dermatological assessment of the painful area.

Dermatological assessment is measured by Dermatological Assessment Scale (scale range from 0 (without causing irritation) to 7 (important reaction that extends beyond the assessed area).

Grade of compliance/complacency of treatment.

A patient compliance questionnaire (6 questions) will be self-administered to the patient and must be completed during the follow-up visit.

Full Information

NCT ID

NCT05029297

First Posted

May 19, 2021

Last Updated

September 7, 2021

Sponsor

Arafarma Group, S.A.

Collaborators

Fundación Teófilo Hernando, Spain

1. Study Identification

Unique Protocol Identification Number

NCT05029297

Brief Title

Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy.

Official Title

Study of Efficacy and Non-inferiority, With Two Capsaicin Topic Treatments, for the Moderate to Severe Pain in Diabetic Neuropathy.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 4, 2010 (Actual)

Primary Completion Date

October 23, 2018 (Actual)

Study Completion Date

October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arafarma Group, S.A.

Collaborators

Fundación Teófilo Hernando, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The sponsor created a new pharmaceutical formulation of CAPSAICIN topical solution applicable in roll-on. This new formulation in roll-on represents a line extension of drug ARAFARMADOL 0.075 cream, which is currently marketed in Spain by the sponsor. The proposed investigational product as topical solution applicable in roll-on is expected to solve the compliance and safety issues of the cream with the same indications for use. Eligible patients will be randomized into two groups: CAPSAICIN topical solution applicable in roll-on and CAPSAICIN cream (ARAFARMADOL® ) for 8 weeks. Then, they will have a 4 week washout period and will be crossed over to the other treatment group for 8 weeks. A follow-up period of 2 weeks will take place after the end of both treatments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathy, Painful

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

161 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

CAPSAICIN 0.075% cream

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Capsaicin

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

Baseline to 8 weeks

Secondary Outcome Measure Information:

Title

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

Description

All AEs will be recorded, whether considered minor or serious, drug-related or not.

Time Frame

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

Title

Change from baseline in both treatment groups of QoL.

Description

Time Frame

Baseline to 8 weeks

Title

Treatment compliance in both treatment groups.

Description

Treatment compliance is measured by the use of Morisky-Green test.

Time Frame

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

Title

Change from baseline in both treatment groups of height.

Description

Height measured by cm.

Time Frame

Baseline to every 4 weeks up to 22 weeks.

Title

Change from baseline in both treatment groups of weight.

Description

Weight measured by kg.

Time Frame

Baseline to every 4 weeks up to 22 weeks.

Title

Change from baseline in both treatment groups of blood pressure.

Description

Blood pressure measured by mm Hg.

Time Frame

Baseline to every 4 weeks up to 22 weeks.

Title

Change from baseline in both treatment groups of dermatological assessment of the painful area.

Description

Dermatological assessment is measured by Dermatological Assessment Scale (scale range from 0 (without causing irritation) to 7 (important reaction that extends beyond the assessed area).

Time Frame

Baseline to 8 weeks.

Title

Grade of compliance/complacency of treatment.

Description

A patient compliance questionnaire (6 questions) will be self-administered to the patient and must be completed during the follow-up visit.

Time Frame

Last Follow-Up visit of the study (22nd week).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. History or current problem of substance abuse. Pregnant or lactating women. Women of childbearing potential should use effective contraception. Participation in another clinical trial with any non-marketed investigational drug during the 90 days prior to inclusion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Raffaelle Carraro

Organizational Affiliation

Hospital Universitario La Princesa. Madrid. Investigator Site Coordinator.

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study With Two Capsaicin Topic Treatments in Diabetic Neuropathy.

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