Neuropathic PainPhase 2PAeoNyNCT03559985
Paracetamol and Neuropathic Pain
A Phase 2 study testing paracetamol 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 the analgesic effect of paracetamol in patients suffering from pain with a peripheral neuropathic component in the presence of their usual treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2018to 31 Aug 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 to 65 years,
- Patient suffering from chronic pain (for more than 3 months) with the characteristics of peripheral neuropathy and having pain assessed by a numerical scale ≥ 3 for one week, with at least 10 assessments completed,
- Patient agrees with not to take paracetamol, other than the treatment provided as part of the protocol, from inclusion to completion of the study,
- Acceptance to give a written consent.
Who cannot join
- Patient taking paracetamol daily,
- Patient with a contraindication to paracetamol administration (liver or renal failure, ...),
- Patient with a biological evaluation evaluated by the investigator as not compatible with the trial,
- Patient with a medical and/or surgical history evaluated by the investigator to be not compatible with the trial,
- Patient with drug treatments evaluated by the investigator to be not compatible with the trial,
- Pregnant or nursing woman,
Show all 11Show fewer
- 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...),
- Patient not affiliated to the French Social Security system,
- Paracetamol intake during wash-out period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of Paracetamol in Neuropathic Pain Patients
The aim of this study is to evaluate the analgesic effect of paracetamol in patients suffering from pain with a peripheral neuropathic component in the presence of their usual treatment.
Read the detailed description
This is an interventional, randomized, placebo-controlled, double-blind, crossover study about the use of paracetamol in therapeutic doses in peripheral neuropathic pain patients. The analgesic effect of paracetamol will be assessed by the painful intensity measured by numerical pain rating scale over one week after taking paracetamol/placebo.
The secondary objectives will be:
- To determine the number of patients in whom paracetamol is effective in reducing pain by at least 30% and 50%,
- To evaluate the effect of paracetamol on pain, on the number and intensity of paroxysms,
- To evaluate paracetamol consumption,
- To evaluate the effect of paracetamol on neuropathic pain patient,
- To evaluate the effect of paracetamol on mechanical allodynia,
- To monitor routine biological parameters (liver function),
- Compare Glutathione (GSH) concentrations before and after taking paracetamol,
- To perform a blood test for paracetamol and its metabolites before and after each study period,
- To perform urine dosage of paracetamol and its metabolites before and after each study period,
- To study pharmacogenetics parameters,
- To evaluate patient feeling and satisfaction after taking paracetamol,
- To evaluate the effect of paracetamol on cognition, anxiety, depression and sleep by different questionnaires,
- To collect adverse events.
- Conditions
- Neuropathic Pain
- Being tested
- paracetamol, Placebo comparator
- Keywords
- Paracetamol, Neuropathic pain, Analgesic effect, Pharmacogenetics, Biological parameters, Cognitivo-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.
paracetamolDrug
Period 1 (D1 to D7): 500 mg (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day.
Wash-out period (D8 to D14): patients should not take paracetamol during this week.
Period 2 (D15 to D21): 500 mg per dose (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day.
Placebo comparatorOther
Period 1 (D1 to D7): 500 mg (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day.
Wash-out period (D8 to D14): patients should not take paracetamol during this week.
Period 2 (D15 to D21): 500 mg per dose (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol and placebo comparator (Group 1) | Other | Neuropathic pain patients taking either paracetamol or placebo according to the randomization plan Receives: Drug: paracetamol; Other: Placebo comparator |
| Paracetamol and placebo comparator (Group 2) | Other | Neuropathic pain patients taking either paracetamol (if during period 1 they received placebo) or placebo (if during period 1 they received paracetamol) Receives: Drug: paracetamol; Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity change between period 1 and 2
Pain intensity change between period 1 and 2, measured by numerical pain rating scale (NPRS) over one week (two evaluations per day, morning and evening) following the taking of paracetamol/ placebo.
Measured: Day 1 to Day 7 (one week) and Day 15 to Day 21 (one week).
Secondary outcomes (16)
Treatment responders at 30% (NPRS)
Calculation of the decrease of NPRS by at least 30% between the beginning and the end of the treatment period (at least 30% difference between the average of four NPRS measurements over 2 days before the start of the treatment period and the average of the four NPRS measurements over 2 days at the end of the treatment period). The number of paracetamol responders will be compared to the number of placebo responders.
Measured: During 2 days before period 1 (mean of Day -1 and Day 0) and at the end of period 1 (mean of Day 6 and Day 7); during 2 days before period 2 (mean of Day 13 and Day 14) and at the end of period 2 (mean of Day 20 and Day 21).
Treatment responders at 50% (NPRS)
Calculation of the decrease of NPRS by at least 50% between the beginning and the end of the treatment period (at least 50% difference between the average of four NPRS measurements over 2 days before the start of the treatment period and the average of four NPRS measurements over 2 days at the end of the treatment period). The number of paracetamol responders will be compared to the number of placebo responders.
Measured: During 2 days before period 1 (mean of Day -1 and Day 0) and at the end of period 1 (mean of Day 6 and Day 7); during 2 days before period 2 (mean of Day 13 and Day 14) and at the end of period 2 (mean of Day 20 and Day 21).
Number of paroxysms
The number of paroxysms will be listed by the patient in the daily pain diary during all the study (28 days).
Measured: Before period 1 (Day -6 to Day 0), over a week during period 1 (Day 1 to Day 7), over a week during wash-out (Day 8 to Day 14) and over a week during period 2 (Day 15 to Day 21).
Paroxysms intensity (NPRS)
The average pain of paroxyms will be evaluated by the patient in the daily pain diary during all the study (28 days). The pain intensity will be measured by NPRS: the scale ranges from 0 no pain to 10 maximal tolerable pain
Measured: (Day -6 to Day 0), over a week during period 1 (Day 1 to Day 7), over a week during wash-out (Day 8 to Day 14) and over a week during period 2 (Day 15 to Day 21).
Assessment of paracetamol (and placebo) consumption
The number of paracetamol (and placebo) capsules intake will be listed by the patient in the pain diary during the 4 weeks of the study.
Measured: At Day1, Day8, Day15, Day22
Assessment of dynamic mechanical allodynia
Dynamic mechanical allodynia (DMA) will be evaluated by a standardized fine filament brush (Somedic, ~200-400mN) which will be moved laterally, slowly and without support, with a movement back and forth over an area of skin. Patients will be seated comfortably in a quiet room. This light touch will be applied 5 times. The sensation perceived by the patient, during each stimulus, will be rated using an ENV (0 - 10), where a score of 0 equals "no pain" and a score of 10 equals "pain maximum imaginable". The DMA will be quantified as the geometric mean of all scores corresponding to each stimulation
Measured: At Day1, Day8, Day15, Day22
Assessment of liver and renal functions
A tube will be taken for biochemistry analysis of alanine amino transferase, aspartate aminotransferase and bilirubin to assess the liver function and creatine level to assess the renal function at each visit. The assays will be carried out by the medical biochemistry laboratory of Clermont-Ferrand University Hospital.
Measured: At Day-6, Day1, Day8, Day15, Day22
Blood dosage of glutathione
In order to measure the plasma glutathione level, a blood sample will be taken at each visit. After centrifugation, an aliquot will be performed to recover the plasma. The tubes will be frozen at -80°C for subsequent dosage.
Measured: At Day-6, Day1, Day8, Day15, Day22
Blood dosage of paracetamol and its metabolites
In order to determine the plasma concentration of paracetamol and its metabolites, four blood samples will be taken at D1, D8, D15 and D22. After centrifugation, an aliquot will be performed to recover the plasma. The tubes will be frozen at -80°C for subsequent dosage.
Measured: At Day1, Day8, Day15, Day22
Urinary dosage of paracetamol and its metabolites
In order to determine the urinary concentration of paracetamol and its metabolites, four urine samples will be taken before and after each study period at D1, D7, D15 and D21 and will be frozen at -20°C for subsequent dosage.
Measured: At Day1, Day7, Day15, Day21
Analysis of pharmacogenetics parameters
Pharmacogenetics screening will focus on the metabolism of paracetamol and more specifically on the detection of the presence of one or more variant(s) of the genes UGT2B15, SULT1A1 and TRPV1. This screening will be performed on a single blood sample on D-6 (first visit). Two tubes will be taken and placed directly in the freezer at -80°C. This biological collection will be kept until the analysis.
Measured: At the pre-selection visit (Day-6).
Impact of paracetamol on patient feeling and satisfaction by Global Patient Impression of Change (PGIC)
This scale is used to assess patient satisfaction with treatment by choosing an answer among 8 responses (ranging from "very strongly enhanced" to "very strongly improved") to reflect their overall health.
Measured: At Day1, Day8, Day15, Day22
Impact of paracetamol on cognitive parameters evaluated by Cantab® tests: Motor Screening Test (MOT), Stocking of Cambridge (SOC), Information Sampling task (IST).
The Cantab® test is a validated tool for exploring cognitive functions. It consists of a choice of tests that explore several cognitive dimensions: Planning (IST), Decision-making (SOC). The tests are done on a computer screen with a record of the score obtained for each test. The scores of the different tests are added and the total score compared between the 2 groups. Patients will be required to complete these tests once during their visits.
Measured: At Day1, Day8, Day15, Day22
Emotional status by Hospital Anxiety and Depression scale (HAD)
The Hospital Anxiety and Depression scale is a self-administered questionnaire in 14 items completed by the patient. It is used to determine the levels of anxiety and depression. Seven of the items relate to anxiety and seven relate to depression. Global score ranges from 0 to 42.
Measured: At Day1, Day8, Day15, Day22
Sleep by the Pittsburgh Sleep Quality Index (PSQI)
This questionnaire consists of 19 items and is used to measure sleep quality. It consists of 7 domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction.
Measured: At Day1, Day8, Day15, Day22
Descriptive analysis of adverse event of paracetamol use.
The adverse event will be reported by the patient on his pain diary during all the study. Furthermore, a daily phone-call will be performed by the team project during the two period of treatment
Measured: Pain diary: over 4 weeks: At the pre-selection visit (Day -6) to the end of the study (Day 22).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start20 Aug 2018
- Primary completion8 Oct 2020
- Study completion31 Aug 2022
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Model description
- After a week of pre-selection (D-6 to D0), each patient will receive successively in random order each of the 2 products (paracetamol and placebo) with one wash-out period of 7 days between each administration.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
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
- NCT03559985
- Sponsor's protocol ID
- CHU-389
- Other IDs
- 2017-004505-40, 2017
- Acronym
- PAeoNy
- Status last verified
- Oct 2022
- First submitted
- 11 May 2018
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gimenez C, Morel V, Pereira B, Pickering ME, Bervas R, Knaggs R, Macian N, Pickering G. Acetaminophen and chronic post-surgical neuropathic pain: a randomized double blind cross-over study. Pain Med. 2026 Oct 26:pnag125. doi: 10.1093/pm/pnag125. Online ahead of print.
PubMed 42929783
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Paracetamol in Neuropathic Pain Patients
- ClinicalTrials.gov ID
- NCT03559985
- Acronym / sponsor ID
- PAeoNy / CHU-389
- Conditions
- Neuropathic Pain
- Keywords
- Paracetamol, Neuropathic pain, Analgesic effect, Pharmacogenetics, Biological parameters, Cognitivo-emotional parameters
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 18 Jun 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 the analgesic effect of paracetamol in patients suffering from pain with a peripheral neuropathic component in the presence of their usual treatment.
Detailed description
This is an interventional, randomized, placebo-controlled, double-blind, crossover study about the use of paracetamol in therapeutic doses in peripheral neuropathic pain patients. The analgesic effect of paracetamol will be assessed by the painful intensity measured by numerical pain rating scale over one week after taking paracetamol/placebo.
The secondary objectives will be:
- To determine the number of patients in whom paracetamol is effective in reducing pain by at least 30% and 50%,
- To evaluate the effect of paracetamol on pain, on the number and intensity of paroxysms,
- To evaluate paracetamol consumption,
- To evaluate the effect of paracetamol on neuropathic pain patient,
- To evaluate the effect of paracetamol on mechanical allodynia,
- To monitor routine biological parameters (liver function),
- Compare Glutathione (GSH) concentrations before and after taking paracetamol,
- To perform a blood test for paracetamol and its metabolites before and after each study period,
- To perform urine dosage of paracetamol and its metabolites before and after each study period,
- To study pharmacogenetics parameters,
- To evaluate patient feeling and satisfaction after taking paracetamol,
- To evaluate the effect of paracetamol on cognition, anxiety, depression and sleep by different questionnaires,
- To collect adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After a week of pre-selection (D-6 to D0), each patient will receive successively in random order each of the 2 products (paracetamol and placebo) with one wash-out period of 7 days between each administration.
| Arm | Type | Receives |
|---|---|---|
| Paracetamol and placebo comparator (Group 1) | Other | Drug: paracetamol, Other: Placebo comparatorNeuropathic pain patients taking either paracetamol or placebo according to the randomization plan |
| Paracetamol and placebo comparator (Group 2) | Other | Drug: paracetamol, Other: Placebo comparatorNeuropathic pain patients taking either paracetamol (if during period 1 they received placebo) or placebo (if during period 1 they received paracetamol) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 18 to 65 years,
- Patient suffering from chronic pain (for more than 3 months) with the characteristics of peripheral neuropathy and having pain assessed by a numerical scale ≥ 3 for one week, with at least 10 assessments completed,
- Patient agrees with not to take paracetamol, other than the treatment provided as part of the protocol, from inclusion to completion of the study,
- Acceptance to give a written consent.
Key exclusion criteria (11 listed)
- Patient taking paracetamol daily,
- Patient with a contraindication to paracetamol administration (liver or renal failure, ...),
- Patient with a biological evaluation evaluated by the investigator as not compatible with the trial,
- Patient with a medical and/or surgical history evaluated by the investigator to be not compatible with the trial,
- Patient with drug treatments evaluated by the investigator to be not compatible with the trial,
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 |
|---|---|---|
| paracetamolPeriod 1 (D1 to D7): 500 mg (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day. Wash-out period (D8 to D14): patients should not take paracetamol during this week. Period 2 (D15 to D21): 500 mg per dose (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day. | Drug | Paracetamol and placebo comparator (Group 1), Paracetamol and placebo comparator (Group 2) |
| Placebo comparatorPeriod 1 (D1 to D7): 500 mg (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day. Wash-out period (D8 to D14): patients should not take paracetamol during this week. Period 2 (D15 to D21): 500 mg per dose (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day. | Other | Paracetamol and placebo comparator (Group 1), Paracetamol and placebo comparator (Group 2) |
Primary outcome
Pain intensity change between period 1 and 2
Time frame: Day 1 to Day 7 (one week) and Day 15 to Day 21 (one week).
Pain intensity change between period 1 and 2, measured by numerical pain rating scale (NPRS) over one week (two evaluations per day, morning and evening) following the taking of paracetamol/ placebo.
16 secondary outcomes
Treatment responders at 30% (NPRS)
Time frame: During 2 days before period 1 (mean of Day -1 and Day 0) and at the end of period 1 (mean of Day 6 and Day 7); during 2 days before period 2 (mean of Day 13 and Day 14) and at the end of period 2 (mean of Day 20 and Day 21).
Treatment responders at 50% (NPRS)
Time frame: During 2 days before period 1 (mean of Day -1 and Day 0) and at the end of period 1 (mean of Day 6 and Day 7); during 2 days before period 2 (mean of Day 13 and Day 14) and at the end of period 2 (mean of Day 20 and Day 21).
Number of paroxysms
Time frame: Before period 1 (Day -6 to Day 0), over a week during period 1 (Day 1 to Day 7), over a week during wash-out (Day 8 to Day 14) and over a week during period 2 (Day 15 to Day 21).
Paroxysms intensity (NPRS)
Time frame: (Day -6 to Day 0), over a week during period 1 (Day 1 to Day 7), over a week during wash-out (Day 8 to Day 14) and over a week during period 2 (Day 15 to Day 21).
Assessment of paracetamol (and placebo) consumption
Time frame: At Day1, Day8, Day15, Day22
Assessment of dynamic mechanical allodynia
Time frame: At Day1, Day8, Day15, Day22
Assessment of liver and renal functions
Time frame: At Day-6, Day1, Day8, Day15, Day22
Blood dosage of glutathione
Time frame: At Day-6, Day1, Day8, Day15, Day22
Blood dosage of paracetamol and its metabolites
Time frame: At Day1, Day8, Day15, Day22
Urinary dosage of paracetamol and its metabolites
Time frame: At Day1, Day7, Day15, Day21
Analysis of pharmacogenetics parameters
Time frame: At the pre-selection visit (Day-6).
Impact of paracetamol on patient feeling and satisfaction by Global Patient Impression of Change (PGIC)
Time frame: At Day1, Day8, Day15, Day22
Impact of paracetamol on cognitive parameters evaluated by Cantab® tests: Motor Screening Test (MOT), Stocking of Cambridge (SOC), Information Sampling task (IST).
Time frame: At Day1, Day8, Day15, Day22
Emotional status by Hospital Anxiety and Depression scale (HAD)
Time frame: At Day1, Day8, Day15, Day22
Sleep by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: At Day1, Day8, Day15, Day22
Descriptive analysis of adverse event of paracetamol use.
Time frame: Pain diary: over 4 weeks: At the pre-selection visit (Day -6) to the end of the study (Day 22).
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Derived from this study: PubMed 42929783Gimenez C, Morel V, Pereira B, Pickering ME, Bervas R, Knaggs R, Macian N, Pickering G. Acetaminophen and chronic post-surgical neuropathic pain: a randomized double blind cross-over study. Pain Med. 2026 Oct 26:pnag125. doi: 10.1093/pm/pnag125. Online ahead of print.
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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.
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 paracetamol 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: stopped early, as of the sponsor's last update on 10 Oct 2022. 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?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
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?
Pain intensity change between period 1 and 2 (time frame: Day 1 to Day 7 (one week) and Day 15 to Day 21 (one week).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559985, which also lists 1 linked publication.
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 10 Oct 2022.