Neuropathic PainPhase 2CLEMANTINENCT03686774
Memantine and Post-mastectomy Neuropathic Pain
A Phase 2 study testing Memantine and no memantine in people with Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The aim of this study is to evaluate if memantine administered for four weeks starting two weeks before surgery induces a decrease in pain intensity at 3 months post-mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Memantine and no memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2019to 31 Jan 2022
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥18 years,
- Patient with a diagnosis of breast cancer, programmed for mastectomy with or without axillary dissection and neoadjuvant chemotherapy,
- Patient able to understand and willing to follow the study protocol,
- Acceptance to give a written consent.
Who cannot join
- Patient with a contraindication to memantine administration (hypertension, severe cardiac or hepatic insufficiency, stroke),
- Patient with diabetes (type I and II),
- Patient with renal insufficiency,
- Patient with drug treatments evaluated by the investigator to be not compatible with the trial,
- Patient treated with specific drugs (amantadine, ketamine, dextromethorphan, L-Dopa, dopaminergic, anticholinergic agonists, barbituric, neuroleptic, IMAO, antispastic agents, dantrolen or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine),
- Patient with alcohol addiction,
Show all 11Show fewer
- Epileptic patient or history of epileptic seizure or convulsions,
- Pregnant or nursing woman,
- Patient with a cooperation and an understanding that does not allow for a strict compliance under the conditions set out in the protocol,
- Patient participating in another clinical trial, or being in an exclusion period, or having received a total amount of compensation exceeding 4500 euros over the 12 months preceding the start of the trial,
- Patient benefiting from a legal protection measure (curatorship, guardianship, protection of justice...),
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Gisèle PICKERING
About this study
Official title: Effect of Oral Administration of Memantine in Pre and Post-surgery in the Prevention of Post-mastectomy Neuropathic Pain
The aim of this study is to evaluate if memantine administered for four weeks starting two weeks before surgery induces a decrease in pain intensity at 3 months post-mastectomy.
Read the detailed description
This is a randomized, controlled, open-label study in patients undergoing mastectomy. Patients included in this trial will receive memantine or not. For patients in the "memantine" group, the treatment will be given in titration (maximum dose of 20 mg/day). Concerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment. Whether it is the "memantine" group or the "usual care" group, visits will be scheduled under the usual following conditions of the participating center.
- Conditions
- Neuropathic Pain
- Being tested
- Memantine, no memantine
- Keywords
- Memantine, post-mastectomy, prophylaxis, Neuropathic pain, Cognitive-emotional parameters
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Women provide written informed consent prior to their participation in the study, during their Anesthesiology visit. After baseline assessments (15 days before surgery: Day 0 - 15) of pain intensity, cognitive, quality of life and quality of sleep questionnaires, participants will be randomized in two parallel groups: "memantine" (n=75) or "usual care" (n=75). Memantine will be given orally for four weeks starting two weeks before surgery. Endpoints will be assessed 15 days (Day 0 + 15), 3 months (Day 0 + 3 months), 6 months (Day 0 + 6 months) et 12 months (Day 0 + 12 months) post-mastectomy. In order to maintain a good compliance and to verify that women do not develop adverse events, patients will be called once a week by phone. A booklet for monitoring will be completed daily by the patient for 3 months from the day of surgery.
no memantineOther
Concerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment
| Study group | Role | What they receive |
|---|---|---|
| Memantine group | Experimental | Memantine will be given orally for four weeks starting two weeks before surgery. Memantine will be given in increasing doses: 5 mg/day for 3 days; 10 mg/day for 3 days; 15 mg/day for 3 days and 20 mg/day for 5 days. Receives: Drug: Memantine |
| Usual care group | Other | Concerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment. Receives: Other: no memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain rating scale (NPRS)
The primary endpoint is the measure of the average pain intensity assessed over the 5 days prior to the 3-month post-surgery visit by NPRS, in the "memantine" and "usual care" groups. This scale ranges from 0 no pain to 10 maximal tolerable pain.
Measured: over the 5 days prior to the 3-month post-surgery visit
Secondary outcomes (11)
Analgesic consumption
Post-operative evaluation of analgesic consumption during 12 months, particularly morphine consumption with a daily pain diary and weekly phone call.
Measured: Over 12 months
Neuropathic pain characteristics
Neuropathic Pain in 4 questions" (DN4): DN4 is a clinical tool for the diagnosis of neuropathic pain. This questionnaire has four questions divided into 10 items related to the interview (ie, symptoms) and to the sensory examination (ie, signs). The investigator asks and examines the patient and notes a response "no" or "yes" for each item: "yes" is scored as "1" and "no" is scored as "0". The sum of scores gives the total score of the patient (/10). DN4 is considered as positive if the patient obtains a score of 4/10.
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Neuropathic pain evaluation by Neuropathic pain symptom Inventory (NPSI) questionnaire.
NPSI is a self-questionnaire and includes 10 pain descriptors. Intensity is rated on 0 to 10 numerical scales and two temporal items are designed to assess spontaneous ongoing pain duration and the number of pain paroxysms over 24 hours. This questionnaire discriminates five distinct clinically relevant dimensions: spontaneous burning pain, spontaneous deep pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia. Each item is calculated on 10 and the overall test score is scored on 100.
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Pain evaluation by the Brief Pain Inventory (BPI).
Brief Pain Inventory is a self-administered questionnaire with seven items that measured how much pain interfered with various daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Pain evaluation by the McGill Pain questionnaire
This questionnaire allows to describe pain experienced during the last 48 hours. It has fifty eight qualifiers divided into sixteen items (A to P). Each qualifier is rated from 0 to 4, where 0 = absent, 1 = low, 2 = moderate, 3 = strong, 4 = very strong. The score is divided between two subclasses, sensory subclass (items A to I) and emotional subclass (items J to P).
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Assessment of cognitive parameters by the trail making test (TMT).
This non-verbal cognitive test assesses the ability of speed, executive functions, attention, concentration, visual perceptual speed. The test takes place in two parts. In Part A, circles are numbered from 1 to 25 and the patient must connect with lines the numbers in ascending order (1-2-3-4, etc.). In Part B, the circles contain numbers from 1 to 13 and letters from A to L, the patient must connect the circles with lines but alternating numbers and letters (1A-2B -3C, etc.). The patient must connect the circles as quickly as possible for both parts of the test, without lifting the pen from the paper. The TMT B additionally provides an estimate of mental flexibility.
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Assessment of cognitive parameters by the Digit symbol substitution test (DSST).
DSST is a neuropsychological, nonverbal test, which assesses cognitive deficit and brain damage associated with aging and/or depression. It also evaluates learning ability, concentration and attention. It consists in combining pairs of symbols and numbers as quickly as possible and the score is the correct number of symbols in the time allowed (e.g. 90 or 120 seconds).
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Assessment of cognitive parameters with the Functional Assessment of Cancer Therapy Cognitive Function (FACT-COG).
The items are rated using a 5-point Likert scale ranged 0 from 4. This questionnaire is composed by four subscales: 2 subscales ranged as following: 0 (never), 1 (one time a week), 2 (two to three times a week), 3 (every day) and 4 (several times a day): Perceived cognitive impairments subscale and comments from others subscale and two others subscale ranged as following: 0 (not at all), 1 (a little), 2 (moderately), 3 (much) and 4 (enormously): Perceived cognitive abilities and impact of quality of life subscales. The total score is obtained with the sum of these 4 subscales
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Quality of life assessment by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30).
The average of some questions lead to the score of 15 subscales reported on 100: 9 subscales consisting of several items: 5 subscales measuring functional status (physical, role, social, emotional, cognitive), three subscales measuring symptoms (fatigue, pain, nausea and vomiting) and a global subscale of quality of life and health. Finally, six items/isolated symptoms, covering cancer symptoms and frequent side effects of cancer therapies (e.g. loss of appetite) are also included in the questionnaire. For the 6 item assessing the isolated symptoms and some subscales assessing functional status (as physical, role, social cognitive, emotional) and subscales measuring symptoms (fatigue, pain nausea and vomiting): higher values represent a worse outcome. Concerning subscale of quality of life and health, higher values represent a better outcome.
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Anxiety and depression assessment with the Hospital Anxiety and Depression scale (HAD).
The anxiety sub-score is obtained by summing items relate to anxiety (Subscore Anxiety (A): /21). The depression sub-score is obtained by summing items relate to depression (subscore Depression: /21). For each of the two subscores, if a subject obtain a score ranged from: 0 to 7, he is considered as "normal"; 8-10 = Borderline abnormal (borderline case) and 11-21 = Abnormal (case).
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Sleep assessment with the Pittsburgh Sleep Quality Index (PSQI)
The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction).In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas
Measured: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start15 Feb 2019 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686774
- Sponsor's protocol ID
- CHU-407
- Other IDs
- 2016-004930-75, 2016
- Acronym
- CLEMANTINE
- Status last verified
- Feb 2019
- First submitted
- 18 Sep 2018
- Last updated
- 4 Feb 2019
- 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 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Administration of Memantine in Pre and Post-surgery in the Prevention of Post-mastectomy Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03686774
- Acronym / sponsor ID
- CLEMANTINE / CHU-407
- Conditions
- Neuropathic Pain
- Keywords
- Memantine, post-mastectomy, prophylaxis, Neuropathic pain, Cognitive-emotional parameters
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 27 Sep 2018 (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.
The aim of this study is to evaluate if memantine administered for four weeks starting two weeks before surgery induces a decrease in pain intensity at 3 months post-mastectomy.
Detailed description
This is a randomized, controlled, open-label study in patients undergoing mastectomy. Patients included in this trial will receive memantine or not. For patients in the "memantine" group, the treatment will be given in titration (maximum dose of 20 mg/day). Concerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment. Whether it is the "memantine" group or the "usual care" group, visits will be scheduled under the usual following conditions of the participating center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine group | Experimental | Drug: MemantineMemantine will be given orally for four weeks starting two weeks before surgery. Memantine will be given in increasing doses: 5 mg/day for 3 days; 10 mg/day for 3 days; 15 mg/day for 3 days and 20 mg/day for 5 days. |
| Usual care group | Other | Other: no memantineConcerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient ≥18 years,
- Patient with a diagnosis of breast cancer, programmed for mastectomy with or without axillary dissection and neoadjuvant chemotherapy,
- Patient able to understand and willing to follow the study protocol,
- Acceptance to give a written consent.
Key exclusion criteria (11 listed)
- Patient with a contraindication to memantine administration (hypertension, severe cardiac or hepatic insufficiency, stroke),
- Patient with diabetes (type I and II),
- Patient with renal insufficiency,
- Patient with drug treatments evaluated by the investigator to be not compatible with the trial,
- Patient treated with specific drugs (amantadine, ketamine, dextromethorphan, L-Dopa, dopaminergic, anticholinergic agonists, barbituric, neuroleptic, IMAO, antispastic agents, dantrolen or baclofen, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine),
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 |
|---|---|---|
| MemantineWomen provide written informed consent prior to their participation in the study, during their Anesthesiology visit. After baseline assessments (15 days before surgery: Day 0 - 15) of pain intensity, cognitive, quality of life and quality of sleep questionnaires, participants will be randomized in two parallel groups: "memantine" (n=75) or "usual care" (n=75). Memantine will be given orally for four weeks starting two weeks before surgery. Endpoints will be assessed 15 days (Day 0 + 15), 3 months (Day 0 + 3 months), 6 months (Day 0 + 6 months) et 12 months (Day 0 + 12 months) post-mastectomy. In order to maintain a good compliance and to verify that women do not develop adverse events, patients will be called once a week by phone. A booklet for monitoring will be completed daily by the patient for 3 months from the day of surgery. | Drug | Memantine group |
| no memantineConcerning the comparator group, patients will be followed in the same way as those in the "memantine" group except that they will not receive the study treatment | Other | Usual care group |
Primary outcome
Numerical pain rating scale (NPRS)
Time frame: over the 5 days prior to the 3-month post-surgery visit
The primary endpoint is the measure of the average pain intensity assessed over the 5 days prior to the 3-month post-surgery visit by NPRS, in the "memantine" and "usual care" groups. This scale ranges from 0 no pain to 10 maximal tolerable pain.
11 secondary outcomes
Analgesic consumption
Time frame: Over 12 months
Neuropathic pain characteristics
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Neuropathic pain evaluation by Neuropathic pain symptom Inventory (NPSI) questionnaire.
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Pain evaluation by the Brief Pain Inventory (BPI).
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Pain evaluation by the McGill Pain questionnaire
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Assessment of cognitive parameters by the trail making test (TMT).
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Assessment of cognitive parameters by the Digit symbol substitution test (DSST).
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Assessment of cognitive parameters with the Functional Assessment of Cancer Therapy Cognitive Function (FACT-COG).
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Quality of life assessment by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30).
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Anxiety and depression assessment with the Hospital Anxiety and Depression scale (HAD).
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Sleep assessment with the Pittsburgh Sleep Quality Index (PSQI)
Time frame: At baseline (15 days before surgery: Day 0 - 15 days), visit 3 (Day 0 + 16 days), visit 4 (Day 0 + 3 months), visit 5 (Day 0 + 6 months) and visit 6 (Day 0 + 12 months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
Related trials for Neuropathic Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
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.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine and no memantine in people with Neuropathic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 11 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 4 Feb 2019. 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 France. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale (NPRS) (time frame: over the 5 days prior to the 3-month post-surgery visit). 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 4 Feb 2019.