PainPhase 1NCT02666846
Assess the Efficacy and Safety in Volunteers of DCF100, TIB200 and SPR300 vs. Placebo and Control(s) in a UV Pain Model
A Phase 1 study testing Ibuprofen, Diclofenac and Methyl-salicylate / Menthol in people with Pain, run by Futura Medical Developments Ltd. at 1 site in United Kingdom.
Trial summary
This is a randomised, double blind, cross over clinical study in healthy human volunteers (including pharmacokinetic [PK] sampling and laser Doppler assessment of local blood flow in a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three different topical analgesics (DCF100, TIB200… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Ibuprofen, Diclofenac and Methyl-salicylate / Menthol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to May 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Were able to provide written informed consent.
- Male between 18 and 65 years old, inclusive, at the time of screening.
- Good general health as ascertained by detailed medical history and physical examination.
- Body mass index (BMI) ≥18 and ≤29 kg/m2 (BMI = weight/height2), at the time of screening.
- No clinically relevant abnormalities in 12-lead ECG as per PI's judgement, e.g., absence of cardiac rhythm disorder, in particular bradycardia (<40 beats per minute), conduction abnormalities such as atrioventricular block, absence of active ischemia (such as unstable angina pectoris) or recent myocardial infarction, no QTcF interval >450 milliseconds, no QRS complex ≥120 milliseconds, at Screening.
- No clinically relevant abnormalities in results of laboratory tests as per PI's judgement; in particular, no significant liver impairment defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT) 1.5x upper limit of normal (ULN); no significant kidney impairment defined as serum creatinine 2x ULN; abnormal thyroid function as defined by thyroid-stimulating hormone (TSH) and total thyroxin (T4) (TSH within range 0.27 to 4.2 mIU/L, total T4 within range 59 to 154 nmol/L).
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- Had a skin type II or III (Fitz Patrick classification).
- Non-smokers or ex-smokers for at least 6 months prior to the Screening Visit, as confirmed by a urine cotinine test.
- Subjects were able to communicate well with the PI/designee. -
Who cannot join
- History of hypersensitivity to the IMP or any of the excipients or to medicinal products with similar chemical structures.
- Presence of any clinically relevant acute or chronic disease which could interfere with the subject safety during the study, expose the subject to undue risk, limit the biological sampling (e.g., blood collection), interfere with the absorption of the IMP (e.g., active dermatological conditions at the application sites, or ulcers, irritable bowel syndrome) or interfere with the study objectives.
- Skin type I, IV, V or VI (Fitzpatrick Classification).
- History of chronic pain symptoms (>6 months) or ongoing pain.
- Any condition that required regular concomitant medication including herbal products, or predicted need of any concomitant medication from Screening Visit until the end of the study.
- Intake of any medication including over the counter (OTC) medication (in particular any pain killers), herbal and dietary supplements such as St John's Wort, vitamins and minerals that could affect the outcome of the study, within 48 hours before the first administration of the investigational product and for the duration of the study.
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- Use of photosensitising medication, such as phenothiazines, tetracyclines, quinolones, sulphonamides, nalidixic acid, non-steroidal anti-inflammatories, furosemides, hydrochlorothiazides, fibrate, phytotherapeutic drugs (herbal supplements), phenothiazines, quinidines, psoralens and amiodarone within 4 weeks before the first UVB irradiation and for the duration of the study.
- Any skin disease, acute or chronic (e.g., psoriasis vulgaris, neurodermatitis) or auto immune diseases associated with increased light sensitisation.
- Any active dermatological conditions, local pigmentary disorders, body art (e.g., tattoos), or excessive hair growth at the lower back that might interfere with the study assessments or absorption of the IMP.
- History of skin cancer (i.e., melanoma, squamous cell carcinoma or basal cell carcinoma).
- History of conditions that increase risk for melanoma (e.g., dysplastic nevus [>5 nevi], xeroderma pigmentosum, Fanconi anaemia, Bloom's syndrome, Werner syndrome, Cockayne syndrome, trichothiodystrophy, or familial mole melanoma syndrome).
- History of bleeding disorders, peptic ulceration or gastro intestinal bleeding, heart burn, cardiovascular disease, myocardial infarction or stroke.
- Inability to give reproducible HPPT ratings on naïve skin at screening, (defined as HPTT test re-test difference ≥1.0 °C)
- Heat pain perception threshold <40°C or >51°C on naïve skin at Screening.
- Supine systolic blood pressure (SBP) <90 mmHg or >140 mmHg, or supine diastolic blood pressure (DBP) <50 mmHg or >90 mmHg after 5 minutes supine, at the Screening Visit.
- Positive test results for HBsAg, HCVAb or HIV-1 and/or -2 antibodies at Screening.
- Excessive use of caffeine-containing beverages exceeding 500 mg caffeine/day (5 cups of coffee) and the inability to refrain from the use of caffeine-containing beverages during confinement in the Clinical Unit.
- Excessive alcohol consumption (regular alcohol intake ≥21 units per week). Use of alcohol 48 hours before any study visit, as confirmed by urine alcohol testing at Screening, Day -2, and with any additional tests at the discretion of the PI.
- History in the last year or presence of drug addiction (positive urine drug screen) at Screening and Day -2.
- Presence or history of alcohol abuse in the last year, as confirmed by subject's general practitioner (GP).
- Blood donation within 8 weeks before the first IMP administration.
- Participation in another study with an experimental drug within 3 months before the first dosing day.
- Any psychological, emotional problems, any disorder or resultant therapy that was likely to invalidate informed consent, or limited the ability of the subject to comply with the protocol requirements.
- Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for Follow-up visits and improbability of completing the clinical study.
- Planned surgery, dental procedure, or hospitalisation from the Screening Visit until the end of the study.
- Inability to give written informed consent or to comply fully with the protocol.
- Subjects who, in the opinion of the PI, were considered unsuitable for any other reason.
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
PAREXEL EPCU Northwick Park
Harrow, Middlesex, HA1 3UJ
About this study
Official title: A Randomised, Double Blind, Cross Over Clinical Study in Healthy Human Volunteers to Assess the Efficacy and Safety of Three Different Topical Analgesics (DCF100, TIB200 And SPR300) Versus in a Model of UV-Induced Inflammatory Pain
This is a randomised, double blind, cross over clinical study in healthy human volunteers (including pharmacokinetic [PK] sampling and laser Doppler assessment of local blood flow in a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s) in a model of UV-induced inflammatory pain.
Read the detailed description
This is a randomised, double blind, cross over clinical study in healthy human volunteers, including pharmacokinetic (PK) sampling and laser Doppler assessment of local blood flow in a subset of up to 6 subjects per cohort, to assess the efficacy and safety of three different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s) in a model of UV-induced inflammatory pain. The study will consist of 3 cohorts of subjects (n=20 subjects per cohort). Subjects of each cohort will receive test and reference products (no reference product for Cohort 3) of one investigational medicinal product (IMP) and a placebo.
Test Products:
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w) Cohort 2: Diclofenac, DCF100 gel (2% or 4%, w/w) Cohort 3: Methyl-salicylate and Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate to Menthol)
Reference Products:
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w), Ibuprofen, Nurofen, oral tablet (400 mg) Cohort 2: Voltaren Emulgel (2%), Voltarol oral tablet (50 mg)
Placebo:
All Cohorts:Test product matching vehicle gel.
Pharmacodynamic tests and PK blood draws will be performed at: pre-dose, 1, 2, 4, and 6 hours post dose for all treatment cohorts and treatment days (PK blood sampling in up to 6 subjects per cohort only).
Safety will be evaluated by the incidence of local and systemic treatment-emergent adverse events (TEAEs) reported after each treatment. Safety assessments will also include vital signs, 12-Lead Electrocardiograms (ECGs), laboratory tests and a physical examination at Screening and the Follow-up visit.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called TIB200 gel 10%, Nurofen gel 10%, Nurofen tablets
DiclofenacDrug
Also called DCF100 gel 2%, DCF100 gel 4%, Voltaren gel 2%, Voltaren oral tablet
Methyl-salicylate / MentholDrug
Also called SPR300 gel (15%/7%)
PlaceboDrug
Also called TIB200 placebo gel, DCF100 placebo gel and SPR300 placebo gel
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: TIB200 gel 10% | Experimental | All Cohort 1 participants: TIB200 gel (10%, w/w ibuprofen) Receives: Drug: Ibuprofen |
| Cohort 1: Nurofen gel 10% | Active comparator | All Cohort 1 participants: Nurofen Max Strength gel (10%, w/w ibuprofen) Receives: Drug: Ibuprofen |
| Cohort 1: Nurofen tablets | Active comparator | All Cohort 1 participants: Nurofen oral tablets (2 x 400 mg ibuprofen) Receives: Drug: Ibuprofen |
| Cohort 1: TIB200 Placebo gel | Placebo comparator | All Cohort 1 Participants: TIB200 matching placebo gel Receives: Drug: Placebo |
| Cohort 2: DCF100 gel 2% | Active comparator | All Cohort 2 Participants: DCF100 gel (2% w/w diclofenac) Receives: Drug: Diclofenac |
| Cohort 2: DCF100 gel 4% | Experimental | All Cohort 2 Participants: DCF100 gel (4% w/w diclofenac) Receives: Drug: Diclofenac |
| Cohort 2: Voltaren gel 2% | Active comparator | All Cohort 2 Participants: Voltaren Emulgel (2% diclofenac) Receives: Drug: Diclofenac |
| Cohort 2: Voltarol oral tablet | Active comparator | All Cohort 2 Participants: Voltarol oral tablet (50 mg - diclofenac) Receives: Drug: Diclofenac |
| Cohort 2: DCF100 Placebo gel | Placebo comparator | All Cohort 2 Participants: DCF100 matching placebo gel Receives: Drug: Placebo |
| Cohort 3: SPR300 gel (15%:7%) | Active comparator | All Cohort 3 Participants: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol) Receives: Drug: Methyl-salicylate / Menthol |
| Cohort 3: SPR300 Placebo gel | Placebo comparator | All Cohort 3 Participants: SPR300 matching placebo gel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat Pain Tolerance Test (HPTT) Measured the Point at Which the Heat Became Painful - Degrees Centigrade -
To assess the pharmacodynamic effect by Heat Pain Tolerance Test (HPTT) which measured the point at which the heat became painful (degrees centigrade) of three topical analgesics, DCF100, TIB200, and SPR300 versus topical placebo and active topical reference products in a model of UV-induced inflammatory pain.
Measured: 15 minutes before to 6 hours post administration
Intensity of the UVB-induced Erythema (Determined by Assessment of Skin Blood Flow by Laser Doppler Imaging [Flux Units])
Intensity of the Ultra Violet B radiation (UVB)-induced erythema (determined by assessment of skin blood flow by laser Doppler imaging [flux units], up to 8 subjects per cohort) - Change from baseline
Measured: 15 minutes before to 6 hours post administration
Secondary outcomes (6)
Peak Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax), time corresponding to occurrence of Cmax (tmax) (up to 6 subjects per cohort only) laser Doppler imaging [flux units], up to 6 subjects per cohort)
Measured: 15 minutes before and 1, 2, 4 and 6 hours post administration
Area Under the Plasma Concentration Versus Time Curve
Area under the concentration vs. time curve from time zero to 6 hours (AUC0-6h) (up to 6 subjects per cohort only) laser Doppler imaging [flux units], up to 6 subjects per cohort)
Measured: 15 minutes before and 1, 2, 4 and 6 hours post administration
Number of Recorded Abnormal Clinical Assessments
Laboratory assessments - standard clinical trial assessments for clinical chemistry and haematology
Listing of individual laboratory measurements by subjects and evaluation of each laboratory parameter
Measured: Estimated study duration for each subject will be approximately 6 weeks
Physical Exams to Ensure Safety and Well Being of the Subjects
Physical examinations - including assessments of the application site. examination.
Measured: Estimated study duration for each subject will be approximately 6 weeks
Adverse Events (AEs)
Local and systemic Adverse Events (AEs).
Measured: Estimated study duration for each subject will be approximately 6 weeks
To Determine Vital Signs and Electrocardiograms (ECGs) That Were Abnormal to Ensure Safety and Well Being of the Subjects
To determine Vital Signs and Electrocardiograms (ECGs) that were abnormal to ensure safety and well being of the subjects
Measured: Estimated study duration for each subject will be approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Futura Medical Developments Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Annelize Koch, MBChB, Principal investigator, PAREXEL Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666846
- Sponsor's protocol ID
- FM52
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2016
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Cross Over Clinical Study in Healthy Human Volunteers to Assess the Efficacy and Safety of Three Different Topical Analgesics (DCF100, TIB200 And SPR300) Versus in a Model of UV-Induced Inflammatory Pain
- ClinicalTrials.gov ID
- NCT02666846
- Acronym / sponsor ID
- FM52
- Conditions
- Pain
- Keywords
- UVB Pain Model, PK, Topical, NSAIDs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Futura Medical Developments Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Posted 29 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised, double blind, cross over clinical study in healthy human volunteers (including pharmacokinetic [PK] sampling and laser Doppler assessment of local blood flow in a subset of up to 6 subjects per cohort of 20) to assess the efficacy and safety of three different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s) in a model of UV-induced inflammatory pain.
Detailed description
This is a randomised, double blind, cross over clinical study in healthy human volunteers, including pharmacokinetic (PK) sampling and laser Doppler assessment of local blood flow in a subset of up to 6 subjects per cohort, to assess the efficacy and safety of three different topical analgesics (DCF100, TIB200 and SPR300) versus placebo and active control(s) in a model of UV-induced inflammatory pain. The study will consist of 3 cohorts of subjects (n=20 subjects per cohort). Subjects of each cohort will receive test and reference products (no reference product for Cohort 3) of one investigational medicinal product (IMP) and a placebo.
Test Products:
Cohort 1: Ibuprofen, TIB200 gel (10%, w/w) Cohort 2: Diclofenac, DCF100 gel (2% or 4%, w/w) Cohort 3: Methyl-salicylate and Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate to Menthol)
Reference Products:
Cohort 1: Ibuprofen, Nurofen Max Strength gel (10%, w/w), Ibuprofen, Nurofen, oral tablet (400 mg) Cohort 2: Voltaren Emulgel (2%), Voltarol oral tablet (50 mg)
Placebo:
All Cohorts:Test product matching vehicle gel.
Pharmacodynamic tests and PK blood draws will be performed at: pre-dose, 1, 2, 4, and 6 hours post dose for all treatment cohorts and treatment days (PK blood sampling in up to 6 subjects per cohort only).
Safety will be evaluated by the incidence of local and systemic treatment-emergent adverse events (TEAEs) reported after each treatment. Safety assessments will also include vital signs, 12-Lead Electrocardiograms (ECGs), laboratory tests and a physical examination at Screening and the Follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: TIB200 gel 10% | Experimental | Drug: IbuprofenAll Cohort 1 participants: TIB200 gel (10%, w/w ibuprofen) |
| Cohort 1: Nurofen gel 10% | Active comparator | Drug: IbuprofenAll Cohort 1 participants: Nurofen Max Strength gel (10%, w/w ibuprofen) |
| Cohort 1: Nurofen tablets | Active comparator | Drug: IbuprofenAll Cohort 1 participants: Nurofen oral tablets (2 x 400 mg ibuprofen) |
| Cohort 1: TIB200 Placebo gel | Placebo comparator | Drug: PlaceboAll Cohort 1 Participants: TIB200 matching placebo gel |
| Cohort 2: DCF100 gel 2% | Active comparator | Drug: DiclofenacAll Cohort 2 Participants: DCF100 gel (2% w/w diclofenac) |
| Cohort 2: DCF100 gel 4% | Experimental | Drug: DiclofenacAll Cohort 2 Participants: DCF100 gel (4% w/w diclofenac) |
| Cohort 2: Voltaren gel 2% | Active comparator | Drug: DiclofenacAll Cohort 2 Participants: Voltaren Emulgel (2% diclofenac) |
| Cohort 2: Voltarol oral tablet | Active comparator | Drug: DiclofenacAll Cohort 2 Participants: Voltarol oral tablet (50 mg - diclofenac) |
| Cohort 2: DCF100 Placebo gel | Placebo comparator | Drug: PlaceboAll Cohort 2 Participants: DCF100 matching placebo gel |
| Cohort 3: SPR300 gel (15%:7%) | Active comparator | Drug: Methyl-salicylate / MentholAll Cohort 3 Participants: Methyl-salicylate / Menthol, SPR300 gel (15%:7%, w/w; ratio of Methylsalicylate / Menthol) |
| Cohort 3: SPR300 Placebo gel | Placebo comparator | Drug: PlaceboAll Cohort 3 Participants: SPR300 matching placebo gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Were able to provide written informed consent.
- Male between 18 and 65 years old, inclusive, at the time of screening.
- Good general health as ascertained by detailed medical history and physical examination.
- Body mass index (BMI) ≥18 and ≤29 kg/m2 (BMI = weight/height2), at the time of screening.
- No clinically relevant abnormalities in 12-lead ECG as per PI's judgement, e.g., absence of cardiac rhythm disorder, in particular bradycardia (<40 beats per minute), conduction abnormalities such as atrioventricular block, absence of active ischemia (such as unstable angina pectoris) or recent myocardial infarction, no QTcF interval >450 milliseconds, no QRS complex ≥120 milliseconds, at Screening.
Key exclusion criteria (28 listed)
- History of hypersensitivity to the IMP or any of the excipients or to medicinal products with similar chemical structures.
- Presence of any clinically relevant acute or chronic disease which could interfere with the subject safety during the study, expose the subject to undue risk, limit the biological sampling (e.g., blood collection), interfere with the absorption of the IMP (e.g., active dermatological conditions at the application sites, or ulcers, irritable bowel syndrome) or interfere with the study objectives.
- Skin type I, IV, V or VI (Fitzpatrick Classification).
- History of chronic pain symptoms (>6 months) or ongoing pain.
- Any condition that required regular concomitant medication including herbal products, or predicted need of any concomitant medication from Screening Visit until the end of the study.
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 |
|---|---|---|
| IbuprofenAlso: TIB200 gel 10%, Nurofen gel 10%, Nurofen tablets | Drug | Cohort 1: Nurofen gel 10%, Cohort 1: Nurofen tablets, Cohort 1: TIB200 gel 10% |
| DiclofenacAlso: DCF100 gel 2%, DCF100 gel 4%, Voltaren gel 2%, Voltaren oral tablet | Drug | Cohort 2: DCF100 gel 2%, Cohort 2: DCF100 gel 4%, Cohort 2: Voltaren gel 2%, Cohort 2: Voltarol oral tablet |
| Methyl-salicylate / MentholAlso: SPR300 gel (15%/7%) | Drug | Cohort 3: SPR300 gel (15%:7%) |
| PlaceboAlso: TIB200 placebo gel, DCF100 placebo gel and SPR300 placebo gel | Drug | Cohort 1: TIB200 Placebo gel, Cohort 2: DCF100 Placebo gel, Cohort 3: SPR300 Placebo gel |
Primary outcome
Heat Pain Tolerance Test (HPTT) Measured the Point at Which the Heat Became Painful - Degrees Centigrade -
Time frame: 15 minutes before to 6 hours post administration
To assess the pharmacodynamic effect by Heat Pain Tolerance Test (HPTT) which measured the point at which the heat became painful (degrees centigrade) of three topical analgesics, DCF100, TIB200, and SPR300 versus topical placebo and active topical reference products in a model of UV-induced inflammatory pain.
Intensity of the UVB-induced Erythema (Determined by Assessment of Skin Blood Flow by Laser Doppler Imaging [Flux Units])
Time frame: 15 minutes before to 6 hours post administration
Intensity of the Ultra Violet B radiation (UVB)-induced erythema (determined by assessment of skin blood flow by laser Doppler imaging [flux units], up to 8 subjects per cohort) - Change from baseline
6 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: 15 minutes before and 1, 2, 4 and 6 hours post administration
Area Under the Plasma Concentration Versus Time Curve
Time frame: 15 minutes before and 1, 2, 4 and 6 hours post administration
Number of Recorded Abnormal Clinical Assessments
Time frame: Estimated study duration for each subject will be approximately 6 weeks
Physical Exams to Ensure Safety and Well Being of the Subjects
Time frame: Estimated study duration for each subject will be approximately 6 weeks
Adverse Events (AEs)
Time frame: Estimated study duration for each subject will be approximately 6 weeks
To Determine Vital Signs and Electrocardiograms (ECGs) That Were Abnormal to Ensure Safety and Well Being of the Subjects
Time frame: Estimated study duration for each subject will be approximately 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Annelize Koch, MBChB principal investigator
PAREXEL Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ibuprofen, Diclofenac and Methyl-salicylate / Menthol in people with Pain, run by Futura Medical Developments Ltd. at 1 site in United Kingdom.
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 9 inclusion and 28 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 27 Jan 2021. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Heat Pain Tolerance Test (HPTT) Measured the Point at Which the Heat Became Painful - Degrees Centigrade - (time frame: 15 minutes before to 6 hours post administration). The study lists 2 primary outcomes in all. 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 27 Jan 2021.