PainPhase 1NCT01202799
Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel
A Phase 1 study testing 2% w/w diclofenac sodium topical gel, 1.5% w/w diclofenac sodium topical solution and 75 mg diclofenac sodium delayed release tablet in people with Pain, run by Mallinckrodt at 1 site in United States.
Trial summary
It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved PENNSAID solution… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 2% w/w diclofenac sodium topical gel, 1.5% w/w diclofenac sodium topical solution and 75 mg diclofenac sodium delayed release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Nov 2010
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The eligibility of subjects to enter the study is based on meeting the inclusion criteria listed below:
- Signed and dated IRB approved consent before any protocol procedures are performed.
- Males or non-pregnant, non-lactating females, minimum 18 years of age and maximum of 55 years of age.
- Female subjects must be negative on a serum pregnancy test, be postmenopausal for at least 1 year, surgically sterile, or using an acceptable form of contraception for 30 days prior to dosing and for the duration of study participation.
- Subjects with a body mass index (BMI) ≥19 and ≤29 kg/m².
- The findings from the ECG interpretation must be within the normal range.
- Subjects whose health status is assessed by the investigator as "normal healthy" by required screening and check-in assessments.
- Subjects must be able to provide written consent and agree to comply with study requirements.
Who cannot join
- Subjects will be ineligible for the study if they meet any of the following criteria:
- Known hypersensitivity to diclofenac, aspirin [acetylsalicylic acid (ASA)] or any other NSAID, dimethyl sulfoxide (DMSO) or ethanol. This includes subjects exhibiting aspirin or other NSAID-induced symptoms, including bronchospasm, rhinitis, and urticaria or other NSAID-induced allergic symptoms.
- Pregnant or lactating women. Women of reproductive potential (and women <12 months after menopause) may not participate unless they have agreed to use an effective contraceptive method while on study.
- Evidence of any serious active infections, severe uncontrolled cardiac, renal, hepatic, pulmonary or other systemic disease, significant medical or psychiatric illness, known seropositivity to HIV, known unexplained vision changes, history of unexplained syncope, lightheadedness, high blood pressure, chronic hepatic conditions like hepatic porphyria or clinically significant laboratory findings that would, in the investigators judgment, make the subject inappropriate for the study.
- Documented (upper GI series or endoscopy) gastroduodenal ulcer or any GI bleeding (except hemorrhoidal) within the last 6 months prior to screening.
- Abnormal hepatic and renal functions; hematologic changes:
Show all 24Show fewer
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)≥2.5 X ULN
- Gamma-glutamyl transpeptidase (GGT) ≥3X ULN
- Total bilirubin ≥1.5X ULN
- Serum creatinine ≥1.5X ULN
- Hemoglobin ≤LLN.
- Major surgery or previous damage to the study knee(s) at any time (eg. total knee replacement, damage/reconstruction of the anterior or posterior cruciate ligaments), or minor knee surgery (eg, cartilage repair, collateral ligament repair, arthroscopic debridement) to the study knee(s) within 1 year prior to screening.
- Administration of a sedative hypnotic medication for insomnia within 14 days prior to screening.
- Administration of anti-depressants, within 60 days prior to screening.
- Administration of another investigational drug within the previous 30 days prior to screening.
- Skin disorder that affects palms of the hands or the application site of the knee(s).
- History of chronic headaches.
- Documented history of alcohol or drug abuse within 1 year prior to the screening visit
- Subjects who have smoked or used nicotine-containing products within 6 months prior to Period 1 dosing.
- Subjects treated with systemic or local diclofenac within one month of study Day 1.
- Using artificial exposure, tanning beds, or self-tanning cream on knee area within 90 days of study start.
- Donation or significant loss of blood (480 mL or more) within 30 days of dosing.
- Previous participation in this study or participation in another clinical trial within 30 days prior screening.
- Noncompliance with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Single Center, Open-Label, Multiple-Dose, Three-Way Crossover Study to Evaluate the Pharmacokinetics, Bioavailability and Safety of PENNSAID Gel in Comparison With Sandoz 75 mg Diclofenac Sodium Delayed Release Tablet and PENNSAID (Diclofenac Sodium Topical Solution) in Healthy Volunteers
It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved PENNSAID solution administered four times a day (QID).
Read the detailed description
PENNSAID Gel is a new topical gel formulation of diclofenac sodium that is similar in composition to PENNSAID solution.
No clinical studies have been conducted using PENNSAID Gel. The current study will compare the pharmacokinetics, bioavailability, safety and tolerability of diclofenac after the topical application of PENNSAID Gel with the approved formulations of topical PENNSAID Solution and oral Sandoz 75 mg diclofenac sodium delayed release tablets in healthy subjects.
The efficacy profile of PENNSAID Gel is based on the known efficacy profile of PENNSAID solution. Support for the BID dosing regimen includes the higher concentration of diclofenac sodium in PENNSAID Gel (2.0%) compared to PENNSAID solution (1.5%). In addition, compared to PENNSAID solution, PENNSAID Gel is designed to have better penetration of diclofenac to allow for a reduction in the number of applications per day from four to two while maintaining effectiveness.
- Conditions
- Pain
- Being tested
- 2% w/w diclofenac sodium topical gel, 1.5% w/w diclofenac sodium topical solution, 75 mg diclofenac sodium delayed release tablet
- Keywords
- Pharmacokinetics, Healthy volunteers, PENNSAID, Topical NSAID, Diclofenac
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% w/w diclofenac sodium topical gelDrug
2% w/w diclofenac sodium topical gel
1.5% w/w diclofenac sodium topical solutionDrug
1.5% w/w diclofenac sodium topical solution
75 mg diclofenac sodium delayed release tabletDrug
75 mg diclofenac sodium delayed release tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 2% w/w diclofenac sodium topical gel Receives: Drug: 2% w/w diclofenac sodium topical gel |
| Treatment B | Active comparator | Not described Receives: Drug: 1.5% w/w diclofenac sodium topical solution |
| Treatment C | Active comparator | Not described Receives: Drug: 75 mg diclofenac sodium delayed release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate and extent of exposure of diclofenac will be assessed.
Summary statistics including the mean, standard deviation, coefficient of variation, geometric mean and geometric %CV will be calculated for all PK parameters by treatment.
Measured: During each of the 3 periods, blood samples will be obtained on Day 1 and Day 8 at pre-dose and 1, 2, 3, 4, 6, 8 and 12 hours post-dose; on Days 2-7 at pre-dose; and on Days 9, 13 and 15 at approximately 8 AM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionNov 2010
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria J Gutierrez, MD, Principal investigator, Comprehensive Phase One ®
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202799
- Sponsor's protocol ID
- COV05100070
- Status last verified
- Sep 2014
- First submitted
- 7 Sep 2010
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Holt RJ, Taiwo T, Kent JD. Bioequivalence of diclofenac sodium 2% and 1.5% topical solutions relative to oral diclofenac sodium in healthy volunteers. Postgrad Med. 2015 Aug;127(6):581-90. doi: 10.1080/00325481.2015.1058689. Epub 2015 Jun 16.
PubMed 26077436
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Single Center, Open-Label, Multiple-Dose, Three-Way Crossover Study to Evaluate the Pharmacokinetics, Bioavailability and Safety of PENNSAID Gel in Comparison With Sandoz 75 mg Diclofenac Sodium Delayed Release Tablet and PENNSAID (Diclofenac Sodium Topical Solution) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01202799
- Acronym / sponsor ID
- COV05100070
- Conditions
- Pain
- Keywords
- Pharmacokinetics, Healthy volunteers, PENNSAID, Topical NSAID, Diclofenac
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 16 Sep 2010 (estimated)
- 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.
It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved PENNSAID solution administered four times a day (QID).
Detailed description
PENNSAID Gel is a new topical gel formulation of diclofenac sodium that is similar in composition to PENNSAID solution.
No clinical studies have been conducted using PENNSAID Gel. The current study will compare the pharmacokinetics, bioavailability, safety and tolerability of diclofenac after the topical application of PENNSAID Gel with the approved formulations of topical PENNSAID Solution and oral Sandoz 75 mg diclofenac sodium delayed release tablets in healthy subjects.
The efficacy profile of PENNSAID Gel is based on the known efficacy profile of PENNSAID solution. Support for the BID dosing regimen includes the higher concentration of diclofenac sodium in PENNSAID Gel (2.0%) compared to PENNSAID solution (1.5%). In addition, compared to PENNSAID solution, PENNSAID Gel is designed to have better penetration of diclofenac to allow for a reduction in the number of applications per day from four to two while maintaining effectiveness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: 2% w/w diclofenac sodium topical gel2% w/w diclofenac sodium topical gel |
| Treatment B | Active comparator | Drug: 1.5% w/w diclofenac sodium topical solution |
| Treatment C | Active comparator | Drug: 75 mg diclofenac sodium delayed release tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The eligibility of subjects to enter the study is based on meeting the inclusion criteria listed below:
Key exclusion criteria (24 listed)
- Subjects will be ineligible for the study if they meet any of the following criteria:
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 |
|---|---|---|
| 2% w/w diclofenac sodium topical gel2% w/w diclofenac sodium topical gel | Drug | Treatment A |
| 1.5% w/w diclofenac sodium topical solution1.5% w/w diclofenac sodium topical solution | Drug | Treatment B |
| 75 mg diclofenac sodium delayed release tablet75 mg diclofenac sodium delayed release tablet | Drug | Treatment C |
Primary outcome
The rate and extent of exposure of diclofenac will be assessed.
Time frame: During each of the 3 periods, blood samples will be obtained on Day 1 and Day 8 at pre-dose and 1, 2, 3, 4, 6, 8 and 12 hours post-dose; on Days 2-7 at pre-dose; and on Days 9, 13 and 15 at approximately 8 AM.
Summary statistics including the mean, standard deviation, coefficient of variation, geometric mean and geometric %CV will be calculated for all PK parameters by treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2014.
- Derived from this study: PubMed 26077436Holt RJ, Taiwo T, Kent JD. Bioequivalence of diclofenac sodium 2% and 1.5% topical solutions relative to oral diclofenac sodium in healthy volunteers. Postgrad Med. 2015 Aug;127(6):581-90. doi: 10.1080/00325481.2015.1058689. Epub 2015 Jun 16.
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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.
Maria J Gutierrez, MD principal investigator
Comprehensive Phase One ®
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 2% w/w diclofenac sodium topical gel, 1.5% w/w diclofenac sodium topical solution and 75 mg diclofenac sodium delayed release tablet in people with Pain, run by Mallinckrodt at 1 site in United States.
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 8 inclusion and 24 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 23 Sep 2014. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate and extent of exposure of diclofenac will be assessed. (time frame: During each of the 3 periods, blood samples will be obtained on Day 1 and Day 8 at pre-dose and 1, 2, 3, 4, 6, 8 and 12 hours post-dose; on Days 2-7 at pre-dose; and on Days 9, 13 and 15 at approximately 8 AM.). 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 NCT01202799, 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 23 Sep 2014.