Painful Diabetic NeuropathyPhase 3NCT06383702
A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy
A Phase 3 study testing pregabalin sustained-release tablets in people with Painful Diabetic Neuropathy, run by CSPC Ouyi Pharmaceutical Co., Ltd..
Trial summary
This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- pregabalin sustained-release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 15 Apr 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years and ≤ 75 years at screening;
- diagnosed with type 1 or type 2 diabetes for ≥ 1 year;
- diagnosed with distal symmetrical polyneuropathy caused by diabetes (type 1 or type 2), with duration of neuropathic pain associated with diabetic peripheral neuropathy ≥ 6 months;
- clearly understood and voluntarily participated in the study, and signed the informed consent form by themselves.
Who cannot join
- Subjects with other conditions that may confound the assessment of Neuropathic Pain associated with Diabetic Peripheral neuropathy (DPNP), such as: neuropathic pain other than DPNP (cervical spondylosis, carpal tunnel syndrome, spinal stenosis, postherpetic pain, etc.), pain caused by other causes (gout, chronic obstructive arteriosclerosis, arthritis, etc.), and other pain at the assessment site (skin diseases and trauma);
- subjects with known or suspected allergic reactions to various components of pregabalin sustained-release tablets or compounds closely related to paracetamol or paracetamol;
- subjects with clinically significant or unstable diseases, such as but not limited to severe cardiovascular disease, cerebrovascular disease, liver, kidney, respiratory system, blood system, immune system diseases, inflammatory or rheumatic diseases, uncontrolled infection, untreated endocrine diseases, etc., and other conditions that judged by the investigator to influence participation in the trial;
- subjects who have undergone renal transplantation, or are undergoing renal dialysis;
- subjects with uncontrolled narrow-angle glaucoma, uncontrolled seizure history, or uncontrolled or poorly controlled hypertension;
- Pregnant or lactating females or subjects planning to father a child during the trial (including males);
- subjects with a history of drug or alcohol abuse within one year prior to screening; patients who, in the opinion of the investigator, are not suitable for participation in this trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Pregabalin Sustained-Release Tablets for the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuralgia associated with spinal cord injury. Pregabalin extended-release tablets were administered once daily, as a single dose after dinner. Compared with pregabalin capsule formulation, it reduces the frequency of medication and improves patient compliance.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial, the study was designed to evaluate the efficacy and safety of pregabalin sustained-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. The study includes a screening period (3 weeks, including baseline/run-in period), a treatment period (titration period, fixed dose period and withdrawal period), and a follow-up period. During the treatment period participants will receive pregabalin sustained-release tablets/placebo as daily treatment.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- pregabalin sustained-release tablets, Placebo
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalin sustained-release tabletsDrug
Subjects will take pregabalin sustained-release tablets for the duration of 14 weeks. The dosage will include 165 mg daily (for the titration and the withdraw period) and 330 mg daily for the fixed-dose period.
PlaceboDrug
Subjects will take placebo tablets for the duration of 14 weeks. The dosage will include 165 mg daily (for the titration and the withdraw period) and 330 mg daily for the fixed-dose period.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: pregabalin sustained-release tablets | Experimental | Not described Receives: Drug: pregabalin sustained-release tablets |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) mean change at week 13.
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Change from baseline in weekly mean of NRS (numeric rating scale) at week 13 will be recorded
Measured: Week 13
Secondary outcomes (7)
NRS mean change at Weeks 1-12 and 14
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Change from baseline in weekly mean NRS pain score at Weeks 1-12 and 14 during the treatment period will be recorded;
Measured: Weeks 1-12 and 14
Proportion of subjects with NRS change
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Proportion of subjects with ≥ 50% and ≥ 30% change from baseline in weekly mean NRS pain score at Week 13 will be recorded;
Measured: Week 13
Brief McGill Pain Questionnaire (SF-MPQ) score
It is a self-report questionnaire that allows individuals to give their doctor a good description of the quality and intensity of pain that they are experiencing. Users first select a single word from each group that best reflects their pain; then respondents specify their level of pain by indicating a position along a continuous line between two end-points; then subjects chose the numer best represent their current pain intensity (0~5). Change from baseline in SF-MPQ (Brief McGill Pain Questionnaire) total score and each subscale Pain Grading Index (PRI), Visual Analogue Scale (VAS), and Present Pain Intensity (PPI) scores at Weeks 1, 5, 9, 13, and 14 after treatment;
Measured: Weeks 1, 5, 9, 13, and 14
Medical Outcomes Study Sleep Scale (MOS-SS) score
Participants answered a series of 12 questions assessing sleep, with values ranging from 1 to 6, and an additional dichotomous indicator of optimal sleep. All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is then converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. Change from baseline in MOS-SS sleep scale score and each subscale (sleep interference, sleep adequacy, daytime mental status, snoring, shortness of breath upon awakening, and sleep volume) score at Weeks 1, 5, 9, 13, and 14 after treatment;
Measured: Weeks 1, 5, 9, 13, and 14
Hospital Anxiety and Depression Scale (HADS) score
The HADS is a fourteen-item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Change from baseline in HADS (Hospital Anxiety and Depression Scale) score at Weeks 1, 5, 9, 13, and 14 after treatment;
Measured: Weeks 1, 5, 9, 13, and 14
Patient Global Impression of Improvement (PGIC) score
The Patient Global Impression of Change (PGIC) is a patient-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). The PGIC is based on the validated Clinical Global Impression of Change scale. Change from baseline in PGIC (Patient Global Impression of Improvement) score at Weeks 1, 5, 9, 13, 14 after treatment will be recorded;
Measured: Weeks 1, 5, 9, 13, and 14
Clinical Global Impression of Improvement (CGIC) score
The Clinical Global Impression of Change (PGIC) is a clinician-reported instrument that measures change in overall status on a scale ranging from one ("very much improved") to seven ("very much worse"). Change from baseline in CGIC (Clinical Global Impression of Improvement) score at Weeks 1, 5, 9, 13, 14 after treatment;
Measured: Weeks 1, 5, 9, 13, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start15 May 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Model description
- Parallel design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383702
- Sponsor's protocol ID
- HEX1939-002
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 30 Apr 2024
- 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 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Pregabalin Sustained-Release Tablets for the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06383702
- Acronym / sponsor ID
- HEX1939-002
- Conditions
- Painful Diabetic Neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 25 Apr 2024 (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 evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuralgia associated with spinal cord injury. Pregabalin extended-release tablets were administered once daily, as a single dose after dinner. Compared with pregabalin capsule formulation, it reduces the frequency of medication and improves patient compliance.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled trial, the study was designed to evaluate the efficacy and safety of pregabalin sustained-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. The study includes a screening period (3 weeks, including baseline/run-in period), a treatment period (titration period, fixed dose period and withdrawal period), and a follow-up period. During the treatment period participants will receive pregabalin sustained-release tablets/placebo as daily treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel design
| Arm | Type | Receives |
|---|---|---|
| Experimental: pregabalin sustained-release tablets | Experimental | Drug: pregabalin sustained-release tablets |
| Placebo Comparator | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 18 years and ≤ 75 years at screening;
- diagnosed with type 1 or type 2 diabetes for ≥ 1 year;
- diagnosed with distal symmetrical polyneuropathy caused by diabetes (type 1 or type 2), with duration of neuropathic pain associated with diabetic peripheral neuropathy ≥ 6 months;
- clearly understood and voluntarily participated in the study, and signed the informed consent form by themselves.
Key exclusion criteria (7 listed)
- Subjects with other conditions that may confound the assessment of Neuropathic Pain associated with Diabetic Peripheral neuropathy (DPNP), such as: neuropathic pain other than DPNP (cervical spondylosis, carpal tunnel syndrome, spinal stenosis, postherpetic pain, etc.), pain caused by other causes (gout, chronic obstructive arteriosclerosis, arthritis, etc.), and other pain at the assessment site (skin diseases and trauma);
- subjects with known or suspected allergic reactions to various components of pregabalin sustained-release tablets or compounds closely related to paracetamol or paracetamol;
- subjects with clinically significant or unstable diseases, such as but not limited to severe cardiovascular disease, cerebrovascular disease, liver, kidney, respiratory system, blood system, immune system diseases, inflammatory or rheumatic diseases, uncontrolled infection, untreated endocrine diseases, etc., and other conditions that judged by the investigator to influence participation in the trial;
- subjects who have undergone renal transplantation, or are undergoing renal dialysis;
- subjects with uncontrolled narrow-angle glaucoma, uncontrolled seizure history, or uncontrolled or poorly controlled hypertension;
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 |
|---|---|---|
| pregabalin sustained-release tabletsSubjects will take pregabalin sustained-release tablets for the duration of 14 weeks. The dosage will include 165 mg daily (for the titration and the withdraw period) and 330 mg daily for the fixed-dose period. | Drug | Experimental: pregabalin sustained-release tablets |
| PlaceboSubjects will take placebo tablets for the duration of 14 weeks. The dosage will include 165 mg daily (for the titration and the withdraw period) and 330 mg daily for the fixed-dose period. | Drug | Placebo Comparator |
Primary outcome
Numeric Rating Scale (NRS) mean change at week 13.
Time frame: Week 13
The NRS is an 11-point scale ranging from zero ("no pain") to ten ("pain as bad as you can imagine") for self-reporting of pain by patients. Change from baseline in weekly mean of NRS (numeric rating scale) at week 13 will be recorded
7 secondary outcomes
NRS mean change at Weeks 1-12 and 14
Time frame: Weeks 1-12 and 14
Proportion of subjects with NRS change
Time frame: Week 13
Brief McGill Pain Questionnaire (SF-MPQ) score
Time frame: Weeks 1, 5, 9, 13, and 14
Medical Outcomes Study Sleep Scale (MOS-SS) score
Time frame: Weeks 1, 5, 9, 13, and 14
Hospital Anxiety and Depression Scale (HADS) score
Time frame: Weeks 1, 5, 9, 13, and 14
Patient Global Impression of Improvement (PGIC) score
Time frame: Weeks 1, 5, 9, 13, and 14
Clinical Global Impression of Improvement (CGIC) score
Time frame: Weeks 1, 5, 9, 13, and 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pregabalin sustained-release tablets in people with Painful Diabetic Neuropathy, run by CSPC Ouyi Pharmaceutical Co., Ltd..
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) mean change at week 13. (time frame: Week 13). 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 30 Apr 2024.