HealthyPhase 1NCT03074162

Comparison of the Bioavailability of Diclofenac in a Combination Product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) With Two Diclofenac Only Products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, in Healthy Volunteers

A Phase 1 study testing Diclofenac Sodium, Diclofenac & Capsaicin and Diclofenac Sodium Topical Gel in people with Healthy, run by Boehringer Ingelheim at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main objective of this study is to assess the relative systemic bioavailability of diclofenac in the presence and absence of capsaicin by comparing the systemic bioavailability of diclofenac from a combination product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) with two diclofenac only products, Diclofenac Mono… Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Healthy
What is being tested?: Diclofenac Sodium, Diclofenac & Capsaicin and Diclofenac Sodium Topical Gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteSouth Africa
Study dates: 20 Apr 2017to 29 Jun 2017
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Healthy males and females, 18 to 50 years (inclusive) at time of screening.
Body mass index (BMI) between 18.5 and 29.9 kg/m2 (inclusive).
Body mass not less than 50 kg for males and females.
Findings for medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be normal or within laboratory reference ranges for the relevant laboratory tests, unless the PI considers the deviation to be not clinically significant for the purpose of the study.
Non-smokers.
Females, if:

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Not of childbearing potential,
Of childbearing potential, the following conditions are to be met:
Negative pregnancy test.
Not lactating.
Abstaining from sexual activity (if this is the usual lifestyle of the subject) or must agree to use an accepted method of contraception, and agree to continue with the same method throughout the study.
Written informed consent given for participation in the study.
Further inclusion criteria apply.

Who cannot join

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females. One unit (10 g alcohol) is equal to beer (330 mL), wine (200 mL), or distilled spirits (25 mL) per day.
Regular exposure to substances of abuse (other than alcohol) within the past year.
Use of any medication, prescribed or over-the-counter (especially products containing diclofenac or use of other oral nonsteroidal anti-inflammatory drugs [NSAIDS]) or herbal remedies, within 2 weeks before the first administration of Investigational medicinal product (IMP) except if this will not affect the outcome of the study in the opinion of the PI (Principal Investigator) (in collaboration with the Sponsor). In this study the concomitant use of hormonal contraceptives is allowed.
Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for anti-bodies or insulin), whichever is the longer before administration of IMP in this study, at the discretion of the PI.
Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.

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A major illness during the 3 months before commencement of the screening period.
History of hypersensitivity or allergy (acute rhinitis, angioedema, urticaria or bronchial asthma) to the IMP or its excipients or any related medication (Aspirin or any other NSAID).
History of hypersensitivity or allergy to cayenne pepper or other capsaicinoids (paprika plants).
History of bronchospasm or bronchial asthma, arterial hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
History or current diagnosis of gastrointestinal bleeding or peptic ulcer disease.
Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of IMP (Investigational medicinal product) .
Bruises, damaged skin, eczema or wounds on the application site, or the application site inappropriate for applying the IMP in the opinion of the PI (Principal Investigator).
Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa)
Bloemfontein, 9301

Other trials in South Africa

About this study

Official title: A SINGLE CENTER, MULTIPLE DOSE, OPEN-LABEL, RANDOMIZED, THREE-PERIOD CROSSOVER STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF DICLOFENAC IN THE TOPICAL GEL COMBINATION PRODUCT (DICLOFENAC 2% + CAPSAICIN 0.075%) COMPARED TO DICLOFENAC MONO GEL 2% AND VOLTAROL® 12 HOUR EMULGEL 2.32% GEL IN AT LEAST 42 HEALTHY MALES AND FEMALES

In order to examine potential racial differences in pharmacokinetics (PK), the study population will be stratified 50:50, Caucasian versus Black people. With respect to the main objective, additionally a supportive analysis will be performed to investigate the influence of race on the intra-individual bioavailability ratios.

Conditions: Healthy
Being tested: Diclofenac Sodium, Diclofenac & Capsaicin, Diclofenac Sodium Topical Gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diclofenac SodiumDrug
twice daily
Diclofenac & CapsaicinDrug
twice daily
Diclofenac Sodium Topical GelDrug
twice daily

Study groups in NCT03074162
Study group	Role	What they receive
Diclofenac Sodium (A)	Experimental	Not described Receives: Drug: Diclofenac Sodium
Diclofenac & Capsaicin (B)	Experimental	Not described Receives: Drug: Diclofenac & Capsaicin
Diclofenac Sodium Topical Gel	Active comparator	Not described Receives: Drug: Diclofenac Sodium Topical Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-time Curve (AUC) Over One Dosing Interval for Diclofenac at Steady State (AUC0-τ,ss) (τ = 12 Hours) (Day 7)
AUC0-τ,ss, Area under the plasma concentration-time curve (AUC) over one dosing interval at steady state for diclofenac at day 7 (τ = 12 hours). Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and Geometric Means (gMeans) per treatment and race are very similar, only gMeans per treatment and race are presented.
Measured: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Maximum Plasma Concentration During a Dosage Interval (Cmax,ss) Obtained Directly From the Concentration-time Data for Diclofenac at Steady State (Day 7)
Cmax,ss, Maximum plasma of diclofenac concentration during a dosage interval obtained directly from the concentration-time data at steady state for diclofenac on day 7. Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and gMeans per treatment and race are very similar, only gMeans per treatment and race are presented.
Measured: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration

Secondary outcomes (3)

Time to Maximum Observed Plasma Concentration at Steady State for Diclofenac at Steady State (Tmax,ss) (Day 7)
tmax,ss, Time to maximum observed plasma concentration at steady state for diclofenac at day 7 (tmax,ss). Descriptive statistics by race are reported in addition.
Measured: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Average Plasma Concentration (Cav,ss) for Diclofenac at Steady State
Average plasma concentration (Cav,ss) calculated as AUC0-t,ss divided by τ=12 hours (τ is the duration of the dosing interval). Descriptive statistics by race are reported in addition.
Measured: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Percentage Peak-trough Fluctuation (%PTF), Calculated as [100*(Cmax,ss - Cpre,ss)/Cav,ss]
Percentage peak-trough fluctuation (%PTF) which was calculated as [100*(Cmax,ss - Cpre,ss)/Cav,ss] for Diclofenac. Descriptive statistics by race are reported in addition.
Measured: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201729 Jun 2017

First posted8 Mar 2017
Study start20 Apr 2017
Primary completion29 Jun 2017
Study completion29 Jun 2017

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 HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03074162
Sponsor's protocol ID: 1358.2
Status last verified: Feb 2019
First submitted: 3 Mar 2017
Last updated: 1 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A SINGLE CENTER, MULTIPLE DOSE, OPEN-LABEL, RANDOMIZED, THREE-PERIOD CROSSOVER STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF DICLOFENAC IN THE TOPICAL GEL COMBINATION PRODUCT (DICLOFENAC 2% + CAPSAICIN 0.075%) COMPARED TO DICLOFENAC MONO GEL 2% AND VOLTAROL® 12 HOUR EMULGEL 2.32% GEL IN AT LEAST 42 HEALTHY MALES AND FEMALES
ClinicalTrials.gov ID: NCT03074162
Acronym / sponsor ID: 1358.2
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 Apr 2017 (actual)
Primary completion: 29 Jun 2017 (actual)
Study completion: 29 Jun 2017 (actual)
First posted: 8 Mar 2017 (actual)
Results: Posted 1 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Diclofenac Sodium (A)	Experimental	Drug: Diclofenac Sodium
Diclofenac & Capsaicin (B)	Experimental	Drug: Diclofenac & Capsaicin
Diclofenac Sodium Topical Gel	Active comparator	Drug: Diclofenac Sodium Topical Gel

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (13 listed)

Healthy males and females, 18 to 50 years (inclusive) at time of screening.
Body mass index (BMI) between 18.5 and 29.9 kg/m2 (inclusive).
Body mass not less than 50 kg for males and females.
Findings for medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be normal or within laboratory reference ranges for the relevant laboratory tests, unless the PI considers the deviation to be not clinically significant for the purpose of the study.
Non-smokers.

Key exclusion criteria (15 listed)

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females. One unit (10 g alcohol) is equal to beer (330 mL), wine (200 mL), or distilled spirits (25 mL) per day.
Regular exposure to substances of abuse (other than alcohol) within the past year.
Use of any medication, prescribed or over-the-counter (especially products containing diclofenac or use of other oral nonsteroidal anti-inflammatory drugs [NSAIDS]) or herbal remedies, within 2 weeks before the first administration of Investigational medicinal product (IMP) except if this will not affect the outcome of the study in the opinion of the PI (Principal Investigator) (in collaboration with the Sponsor). In this study the concomitant use of hormonal contraceptives is allowed.
Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for anti-bodies or insulin), whichever is the longer before administration of IMP in this study, at the discretion of the PI.

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
Diclofenac Sodiumtwice daily	Drug	Diclofenac Sodium (A)
Diclofenac & Capsaicintwice daily	Drug	Diclofenac & Capsaicin (B)
Diclofenac Sodium Topical Geltwice daily	Drug	Diclofenac Sodium Topical Gel

Primary outcome

Area Under the Plasma Concentration-time Curve (AUC) Over One Dosing Interval for Diclofenac at Steady State (AUC0-τ,ss) (τ = 12 Hours) (Day 7)
Time frame: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
AUC0-τ,ss, Area under the plasma concentration-time curve (AUC) over one dosing interval at steady state for diclofenac at day 7 (τ = 12 hours). Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and Geometric Means (gMeans) per treatment and race are very similar, only gMeans per treatment and race are presented.
Maximum Plasma Concentration During a Dosage Interval (Cmax,ss) Obtained Directly From the Concentration-time Data for Diclofenac at Steady State (Day 7)
Time frame: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Cmax,ss, Maximum plasma of diclofenac concentration during a dosage interval obtained directly from the concentration-time data at steady state for diclofenac on day 7. Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and gMeans per treatment and race are very similar, only gMeans per treatment and race are presented.

3 secondary outcomes

Time to Maximum Observed Plasma Concentration at Steady State for Diclofenac at Steady State (Tmax,ss) (Day 7)
Time frame: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Average Plasma Concentration (Cav,ss) for Diclofenac at Steady State
Time frame: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration
Percentage Peak-trough Fluctuation (%PTF), Calculated as [100*(Cmax,ss - Cpre,ss)/Cav,ss]
Time frame: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration

Results and safety

Results posted to the registry on 1 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A-B-R	8	8
B-R-A	8	8
R-A-B	8	7
R-B-A	8	8
A-R-B	8	8
B-A-R	8	8

Primary outcome: Area Under the Plasma Concentration-time Curve (AUC) Over One Dosing Interval for Diclofenac at Steady State (AUC0-τ,ss) (τ = 12 Hours) (Day 7)

Time frame: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: Hour*nanogram/millilitre (h*ng/mL)

Measure	Diclofenac 2% (A) n = 47	Diclofenac 2% + Capsaicin 0.075% (B) n = 46	Voltarol® 2.32% Gel (R) n = 47
Overall	46.855 (66.01)	40.175 (59.38)	83.644 (64.35)
By race: Black	60.930 (58.76)	53.628 (47.37)	105.670 (42.13)
By race: Caucasian	35.182 (57.46)	29.704 (51.32)	67.513 (73.15)

Diclofenac 2% + Capsaicin 0.075% (B) vs Voltarol® 2.32% Gel (R): Geometric Mean (gMean) Ratio (%): 45.54 (90% CI 40.11 to 51.70), ANOVA
Diclofenac 2% (A) vs Diclofenac 2% + Capsaicin 0.075% (B): Geometric Mean (gMean) Ratio (%): 85.56 (90% CI 74.11 to 98.77), ANOVA

Population analysed: Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.

Primary outcome: Maximum Plasma Concentration During a Dosage Interval (Cmax,ss) Obtained Directly From the Concentration-time Data for Diclofenac at Steady State (Day 7)

Measure	Diclofenac 2% (A) n = 47	Diclofenac 2% + Capsaicin 0.075% (B) n = 46	Voltarol® 2.32% Gel (R) n = 47
Overall	6.7825 (100.12)	5.6964 (66.98)	10.8330 (70.99)
By Race: Black	9.3923 (63.72)	7.3863 (63.86)	14.8040 (49.82)
By Race: Caucasian	4.7551 (116.89)	4.3416 (55.32)	8.1371 (71.96)

Diclofenac 2% + Capsaicin 0.075% (B) vs Voltarol® 2.32% Gel (R): Geometric Mean (gMean) Ratio (%): 49.60 (90% CI 43.39 to 56.71), ANOVA
Diclofenac 2% (A) vs Diclofenac 2% + Capsaicin 0.075% (B): Geometric Mean (gMean) Ratio (%): 83.57 (90% CI 66.33 to 105.31), ANOVA

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until individual subject's end of study, up to approximately 38 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diclofenac 2% (A)	0 of 47 (0%)	9 of 47 (19.1%)	0 of 47
Diclofenac 2% + Capsaicin 0.075% (B)	0 of 46 (0%)	44 of 46 (95.7%)	0 of 46
Voltarol® 2.32% Gel (R)	0 of 47 (0%)	3 of 47 (6.4%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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 Diclofenac Sodium, Diclofenac & Capsaicin and Diclofenac Sodium Topical Gel in people with Healthy, run by Boehringer Ingelheim at 1 site in South Africa.

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 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 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 South Africa. 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 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 1 Mar 2019). 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?

Area Under the Plasma Concentration-time Curve (AUC) Over One Dosing Interval for Diclofenac at Steady State (AUC0-τ,ss) (τ = 12 Hours) (Day 7) (time frame: Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug 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?

On the ClinicalTrials.gov record for NCT03074162.

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 1 Mar 2019.