- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01020279
Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise
June 24, 2010 updated by: X-pert Med GmbH
Multiple-dose, Randomized, Subject and Observer Blinded, Placebo-controlled, Double-dummy Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise
- Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on muscle pain of the calf caused by eccentric contractions
- Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by eccentric contractions
- Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the calf caused by eccentric contractions
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jena, Germany, 07745
- X-pert Med GmbH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed and dated informed consent prior to participation
- Subjects in good health as determined by the Investigator
- Age 18-55
- Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit)
- For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation
Exclusion Criteria:
- Participation in another clinical study within the last 30 days and during the study
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions
- Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- Pregnancy or lactation
- Alcohol or drug abuse
- Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
- Skin lesions, dermatological diseases or tattoo in the treatment areas
- Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose
- Varicosis, thrombophlebitis and other vascular disorders of the lower extremities
- Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
- Pain conditions which might interfere with pain rating during the study, e.g. neuropathic pain
- Significant neurological or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately (e.g. Alzheimer's disease or schizophrenia or other psychosis), that in the investigator's opinion may affect efficacy or safety assessments or may compromise subject safety during the study
- Systemic lupus erythematodes, mixed connective tissue disease
- Major heart disease / uncontrollable hypertension
- Peripheral arterial disease and/or cerebrovascular disease
- History of stroke or myocardial infarction
- GFR < 30 ml/min
- ALT and/or AST levels ≥ 5 times the ULN
- Chronic obstructive pulmonary disease including asthma bronchiale
- Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants including low dose aspirin
- History of pancreatitis or peptic ulcers
- Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
- Reflux esophagitis requiring treatment
- Any other analgesic therapy including cough and cold drugs containing analgesic properties as well as any other substance used for the treatment of pain during the study observation period (Screening to final Visit)
- Any other drug that might alter pain perception like CNS active drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Parallel Group A
Celecoxib 200 mg (Active Comparator) ; Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug)
|
Ketoprofen in Transfersome® gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d. Celecoxib, 200 mg, one capsule b.i.d. |
Other: Parallel Group B
oral Placebo (Placebo Comparator); Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug)
|
Placebo gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d.
Oral placebo, one capsule b.i.d
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain during muscle contraction
Time Frame: Day 7
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain during rest
Time Frame: Day 7
|
Day 7
|
Surface temperature
Time Frame: Day 7
|
Day 7
|
Volume of the lower leg
Time Frame: Day 7
|
Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion
December 7, 2022
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
November 9, 2009
First Submitted That Met QC Criteria
November 23, 2009
First Posted (Estimate)
November 25, 2009
Study Record Updates
Last Update Posted (Estimate)
June 28, 2010
Last Update Submitted That Met QC Criteria
June 24, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Myalgia
- Musculoskeletal Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
- Ketoprofen
Other Study ID Numbers
- XPM-023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Musculoskeletal Pain
-
Sykehuset i Vestfold HFRecruitingBack Pain | Musculoskeletal Pain | Chronic Pain | Musculoskeletal Diseases or Conditions | Pain, Chronic | Musculoskeletal Disorder | Musculoskeletal Neck PainNorway
-
University of Missouri, Kansas CityTerminatedOrthopaedic Related Pain (Musculoskeletal Pain)United States
-
Uppsala UniversityDalarna County Council, Sweden; Center for Clinical Research Dalarna, Sweden; REHSAM, SwedenTerminatedMusculoskeletal Neck Pain | Musculoskeletal Shoulder PainSweden
-
NORCE Norwegian Research Centre ASHelse Sor-Ost; Sykehuset i Vestfold HFCompletedNeck Pain Musculoskeletal | Back Pain Lower BackNorway
-
Stanford UniversityNational Institute of Neurological Disorders and Stroke (NINDS)RecruitingPain | Joint Pain | Pain, Chronic | Chronic Musculoskeletal PainUnited States
-
Massachusetts General HospitalOrthopaedic Trauma AssociationCompleted
-
University of North Carolina, Chapel HillYale University; Duke University; National Institute on Aging (NIA); Indiana University and other collaboratorsCompletedChronic Pain | Acute Musculoskeletal PainUnited States
-
Wayne State UniversityUniversity of MichiganCompleted
-
Wayne State UniversityBlue Cross Blue Shield of Michigan FoundationCompleted
-
Wayne State UniversityUniversity of Southern CaliforniaCompleted
Clinical Trials on Celecoxib, Ketoprofen
-
IDEA AGCompletedOsteoarthritis of the KneePoland, United Kingdom, Czech Republic, Germany
-
ZARS Pharma Inc.CompletedOsteoarthritisUnited States
-
Aziende Chimiche Riunite Angelini Francesco S.p.ACross Research S.A.Completed
-
Hisamitsu Pharmaceutical Co., Inc.CompletedOsteoarthritis of the KneeUnited States
-
Luis Fernando SimonetiFundação de Amparo à Pesquisa do Estado de São PauloCompletedPain | Other Surgical ProceduresBrazil
-
Aswan University HospitalCompletedInfertility, FemaleEgypt
-
BayerTerminatedHemophilia AUnited States
-
University Hospital, AngersCompleted