Peripheral Sensory Neuropathy of Different EtiologiesPhase 3NCT05619328
A Prospective Clinical Trial to Evaluate the Efficacy and Safety of Neurotropic B-Vitamins in Clinically Diagnosed Peripheral Sensory Polyneuropathy of Different Etiologies.
A Phase 3 study testing Vitamin B combination tablet in people with Peripheral Sensory Neuropathy of Different Etiologies, run by Procter and Gamble at 1 site in Mexico.
Trial summary
This study is designed to investigate the efficacy of the Test Product in subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peripheral Sensory Neuropathy of Different Etiologies
- What is being tested?
- Vitamin B combination tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 1 siteMexico
- Study dates
- 6 Sep 2022to 2 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the purpose and risks of the study
- Considered reliable and capable of adhering to protocol, visit schedule, and medication administration instructions
- Demonstrates that participant can successfully complete the study eDiary using electronic device
- Male or female, 18 to 70 years of age (inclusive)
- Subjects with symptoms of peripheral sensory polyneuropathy (measured with MNSI scale)
- NTSS-6 total score at Screening and Baseline: no severe symptoms
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- Duration of peripheral sensory polyneuropathy symptoms ≥6 months
- Blood pressure ≤140/90 mmHg at Screening or taking a stable dose of antihypertensive medication
- Diabetes: diagnosed T1DM or T2DM ≥ 1 year prior Screening, HbA1c <9% at Screening, no severe hyper-/hypoglycemia/ketoacidosis
- Stable on allowed concomitant medication
- Contraception for women of childbearing potential and men with potentially fertile female partner
Who cannot join
- Subjects with genetic, autoimmune, inflammatory and chemotherapy-induced peripheral neuropathy (PN), compressive mononeuropathy of lower extremity
- Subacute onset of peripheral sensory polyneuropathy
- No increase in PN symptoms for 1 y or longer
- Pain in the rest of the body higher than pain in the lower limbs from peripheral sensory polyneuropathy
- Fails to successfully submit eDiary data
- Known hypersensitivity to vitamins B1, B6, or B12
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- Taken vitamin supplement containing vitamins B1, B6, B12, E, D higher than RDA
- Taken alpha lipoic acid
- Taken any cytostatic drug
- Taken anti-epileptics, opioids or other drugs for neuropathic pain management.
- Use of cannabis/cannabidiol
- Taken topical medication that alters sensation of assessment
- Subjects with any active systemic infection or disease that requires antibiotics, antifungals, antiviral agents
- BMI ≥35 kg/m2
- Pregnancy, subjects planning to become pregnant, or breastfeeding subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of the Product Vitamins B1 (100mg), B6 (100 mg), Plus B12 (5 mg) in Tablets in Subjects With Clinically Diagnosed PerIpheral Sensory polyNeuropathy of Different etiologieS (PINS Study)
This study is designed to investigate the efficacy of the Test Product in subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies compared to placebo.
Read the detailed description
This prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase III clinical study is designed to investigate the efficacy and safety of the Test product versus placebo in male and non-pregnant female subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies aged 18 to 70 years.
The study will be conducted in 17 sites in Mexico. 318 patients with clinically diagnosed symptoms of peripheral sensory polyneuropathy of different etiologies who fulfill the inclusion and exclusion criteria will be enrolled and randomized in a 1:1 ratio to receive either oral vitamin B combination daily or matching placebo for 120 days.
The primary and secondary outcome measures will be evaluated at each post-Screening visit. Exploratory outcomes, and safety/tolerability/treatment satisfaction assessments will be evaluated as per schedule of activities.
Approvals were obtained from Local Ethics Committees and from Mexican Regulatory Authority (COFEPRIS).
- Being tested
- Vitamin B combination tablet, Placebo Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B combination tabletDrug
Once daily, with some liquid with or after a meal
Placebo TabletDrug
Once daily, with some liquid with or after a meal
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B combination tablet (B1, B6, B12) | Experimental | Not described Receives: Drug: Vitamin B combination tablet |
| Placebo tablet | Placebo comparator | Not described Receives: Drug: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathy Total Symptom Score-6 (NTSS-6)
The NTSS-6 scale is a validated neuropathy symptoms scale which evaluates the frequency and intensity of 6 neuropathy sensory symptoms in feet and legs such as numbness, prickling sensation, burning/aching/lancinating pain and allodynia.
Measured: 120 days
Secondary outcomes (4)
Quality of Life Questionnaire
The Quality of Life Questionnaire is a reliable, and valid measure of physical and mental health.
Measured: 120 days
modified Toronto Clinical Neuropathy Score (mTCNS) sensory test subscores
The mTCNS is a reliable clinical score with high validity for tracking mild to moderate distal symmetric polyneuropathy (DSP) and is sensitive to early DSP changes.
Measured: 120 days
B vitamins blood levels
Assess the effect of the Test Product on concentrations of vitamins B1, B6, and B12
Measured: 120 days
Safety Data
Safety of Vitamin B combination tablet in patients with peripheral sensory polyneuropathy in the feet comparing the incidence of adverse and serious adverse events, and the incidence of clinically significant laboratory values to Placebo
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
- Incidence of clinically significant laboratory values
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start6 Sep 2022
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Sensory Neuropathy of Different EtiologiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619328
- Sponsor's protocol ID
- CSD2020153
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of the Product Vitamins B1 (100mg), B6 (100 mg), Plus B12 (5 mg) in Tablets in Subjects With Clinically Diagnosed PerIpheral Sensory polyNeuropathy of Different etiologieS (PINS Study)
- ClinicalTrials.gov ID
- NCT05619328
- Acronym / sponsor ID
- CSD2020153
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate the efficacy of the Test Product in subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies compared to placebo.
Detailed description
This prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase III clinical study is designed to investigate the efficacy and safety of the Test product versus placebo in male and non-pregnant female subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies aged 18 to 70 years.
The study will be conducted in 17 sites in Mexico. 318 patients with clinically diagnosed symptoms of peripheral sensory polyneuropathy of different etiologies who fulfill the inclusion and exclusion criteria will be enrolled and randomized in a 1:1 ratio to receive either oral vitamin B combination daily or matching placebo for 120 days.
The primary and secondary outcome measures will be evaluated at each post-Screening visit. Exploratory outcomes, and safety/tolerability/treatment satisfaction assessments will be evaluated as per schedule of activities.
Approvals were obtained from Local Ethics Committees and from Mexican Regulatory Authority (COFEPRIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin B combination tablet (B1, B6, B12) | Experimental | Drug: Vitamin B combination tablet |
| Placebo tablet | Placebo comparator | Drug: Placebo Tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Able to understand the purpose and risks of the study
- Considered reliable and capable of adhering to protocol, visit schedule, and medication administration instructions
- Demonstrates that participant can successfully complete the study eDiary using electronic device
- Male or female, 18 to 70 years of age (inclusive)
- Subjects with symptoms of peripheral sensory polyneuropathy (measured with MNSI scale)
Key exclusion criteria (15 listed)
- Subjects with genetic, autoimmune, inflammatory and chemotherapy-induced peripheral neuropathy (PN), compressive mononeuropathy of lower extremity
- Subacute onset of peripheral sensory polyneuropathy
- No increase in PN symptoms for 1 y or longer
- Pain in the rest of the body higher than pain in the lower limbs from peripheral sensory polyneuropathy
- Fails to successfully submit eDiary data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B combination tabletOnce daily, with some liquid with or after a meal | Drug | Vitamin B combination tablet (B1, B6, B12) |
| Placebo TabletOnce daily, with some liquid with or after a meal | Drug | Placebo tablet |
Primary outcome
Neuropathy Total Symptom Score-6 (NTSS-6)
Time frame: 120 days
The NTSS-6 scale is a validated neuropathy symptoms scale which evaluates the frequency and intensity of 6 neuropathy sensory symptoms in feet and legs such as numbness, prickling sensation, burning/aching/lancinating pain and allodynia.
4 secondary outcomes
Quality of Life Questionnaire
Time frame: 120 days
modified Toronto Clinical Neuropathy Score (mTCNS) sensory test subscores
Time frame: 120 days
B vitamins blood levels
Time frame: 120 days
Safety Data
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin B combination tablet in people with Peripheral Sensory Neuropathy of Different Etiologies, run by Procter and Gamble at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathy Total Symptom Score-6 (NTSS-6) (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.