PharmacokineticPhase 1NCT00745264
Multi-Centre, Open-Label, Two Segment, Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise
A Phase 1 study testing Diractin in people with Pharmacokinetic, run by IDEA AG at 2 sites in Germany.
Trial summary
Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg applied on 2 major joints to 400 mg ketoprofen from Diractin® (100 mg applied to 4 joints - overexposure) 100 mg and 400 mg ketoprofen from Diractin® used concomitant with heat application 100 mg and 400 mg ketoprofen from… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic
- What is being tested?
- Diractin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2007to May 2008
- 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
- All of the following criteria have to be met to include a subject in the study:
- Understands nature and provision of the study
- Have been informed about the study by the investigator and gave signed and dated informed consent prior to participation
- Male and female subjects
- Age 18-55 years
- Subjects in good health as determined by the Investigator
- Woman of childbearing potential using reliable methods of contraception with a low failure rate (i.e. less than 1% per year), e.g. implants, injectables, combined oral contraceptives, reliable intrauterine-devices, vasectomised/ infertile partner or surgically sterile (uterus removed or both tubes tied) or postmenopausal (at least 2 years without periods)
Who cannot join
- 4.2.1 General Exclusion Criteria
- Investigator or any other team member involved directly or indirectly in the conduct of the clinical trial
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions
- Participation in another clinical trial within the last 30 days
- Not willing to refrain from exposing target areas after treatment to excessive ultraviolet light (solar radiation or solarium)
- Pregnancy or lactation
Show all 24Show fewer
- 4.2.2 Medical History Related Exclusion Criteria
- Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen, and ingredients used in pharmaceutical products
- Alcohol or drug abuse
- Malignancy within the past 2 years
- Skin lesions, dermatological diseases or tattoo in the treatment area
- Major surgery 3 months before enrolment
- Impaired haematopoesis and coagulation
- Gastric and duodenal ulcer and gastrointestinal bleedings
- Systemic lupus erythematodes, mixed connective tissue disease
- Major heart disease / uncontrolled hypertension
- Hepatic failure with ALT and/or AST > 2.0 ULN
- Renal failure with serum creatinine levels > 1.5 milligrams/deciliter (mg/dL)
- Varicosis, thrombophlebitis and other vascular disorders of the lower extremities
- Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-sceletal system of the lower limbs
- HIV - Infection
- Blood donation one (1) month before screening and during study
- Hepatitis B and C
- Asthma bronchiale
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Multi-Centre, Open-Label, Two Segment, Parallel Group Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise
- Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg applied on 2 major joints to
- 400 mg ketoprofen from Diractin® (100 mg applied to 4 joints - overexposure)
- 100 mg and 400 mg ketoprofen from Diractin® used concomitant with heat application
- 100 mg and 400 mg ketoprofen from Diractin® used concomitant with moderate exercise
- Conditions
- Pharmacokinetic
- Being tested
- Diractin
- Keywords
- heat, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiractinDrug
100 mg Ketoprofen to 2 joints
DiractinDrug
400 mg ketoprofen to 4 joints
DiractinDrug
100 and 400 mg Ketoprofen used concomittant with heat
DiractinDrug
100 and 400 mg Ketoprofen concomittant with moderate exercise
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | 400 mg Ketoprofen from Diractin to 4 joints Receives: Drug: Diractin |
| 3 | Experimental | 100 and 400 mg Ketoprofen used concomittant with heat Receives: Drug: Diractin |
| 4 | Experimental | 100 and 400 mg Ketoprofen concomittant with moderate exercise Receives: Drug: Diractin |
| 1 | Experimental | 100 mg ketoprofen to 2 joints Receives: Drug: Diractin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDEA AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Egbert Seidel, MD, PhD, Principal investigator, X-pert Med GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745264
- Sponsor's protocol ID
- CL-033-I-04
- Status last verified
- Mar 2009
- First submitted
- 2 Sep 2008
- Last updated
- 20 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre, Open-Label, Two Segment, Parallel Group Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise
- ClinicalTrials.gov ID
- NCT00745264
- Acronym / sponsor ID
- CL-033-I-04
- Conditions
- Pharmacokinetic
- Keywords
- heat, exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IDEA AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 3 Sep 2008 (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.
- Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg applied on 2 major joints to
- 400 mg ketoprofen from Diractin® (100 mg applied to 4 joints - overexposure)
- 100 mg and 400 mg ketoprofen from Diractin® used concomitant with heat application
- 100 mg and 400 mg ketoprofen from Diractin® used concomitant with moderate exercise
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Diractin400 mg Ketoprofen from Diractin to 4 joints |
| 3 | Experimental | Drug: Diractin100 and 400 mg Ketoprofen used concomittant with heat |
| 4 | Experimental | Drug: Diractin100 and 400 mg Ketoprofen concomittant with moderate exercise |
| 1 | Experimental | Drug: Diractin100 mg ketoprofen to 2 joints |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- All of the following criteria have to be met to include a subject in the study:
Key exclusion criteria (24 listed)
- 4.2.1 General Exclusion Criteria
- 4.2.2 Medical History Related Exclusion Criteria
- Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen, and ingredients used in pharmaceutical products
- Alcohol or drug abuse
- Malignancy within the past 2 years
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 |
|---|---|---|
| Diractin100 mg Ketoprofen to 2 joints | Drug | 1 |
| Diractin400 mg ketoprofen to 4 joints | Drug | 2 |
| Diractin100 and 400 mg Ketoprofen used concomittant with heat | Drug | 3 |
| Diractin100 and 400 mg Ketoprofen concomittant with moderate exercise | Drug | 4 |
Primary outcome
Not reported in the source record.
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 20 Mar 2009.
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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.
Egbert Seidel, MD, PhD principal investigator
X-pert Med GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Diractin in people with Pharmacokinetic, run by IDEA AG at 2 sites in Germany.
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 7 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 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
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 20 Mar 2009.