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Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise

This study has been completed.
Sponsor:
Information provided by:
X-pert Med GmbH
ClinicalTrials.gov Identifier:
NCT01020279
First received: November 9, 2009
Last updated: June 24, 2010
Last verified: June 2010
  Purpose
  1. Comparison of the effect of ketoprofen Transfersome® gel (KTG) to placebo gel (PG) on muscle pain of the calf caused by eccentric contractions
  2. Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by eccentric contractions
  3. Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the calf caused by eccentric contractions

Condition Intervention Phase
Musculoskeletal Pain
Drug: Celecoxib, Ketoprofen
Drug: Ketoprofen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by X-pert Med GmbH:

Primary Outcome Measures:
  • Pain during muscle contraction [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain during rest [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Surface temperature [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Volume of the lower leg [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: October 2009
Study Completion Date: January 2010
Arms Assigned Interventions
Parallel Group A
Celecoxib 200 mg (Active Comparator) ; Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug)
Drug: Celecoxib, Ketoprofen

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.

Parallel Group B
oral Placebo (Placebo Comparator); Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug)
Drug: Ketoprofen
Placebo gel, 2 g gel on the calf, 4 g gel on the quadriceps, b.i.d. Oral placebo, one capsule b.i.d

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020279

Locations
Germany
X-pert Med GmbH
Jena, Germany, 07745
Sponsors and Collaborators
X-pert Med GmbH
  More Information

No publications provided

Responsible Party: Dipl. med. Ilka Rother, X-pert Med GmbH
ClinicalTrials.gov Identifier: NCT01020279     History of Changes
Other Study ID Numbers: XPM-023
Study First Received: November 9, 2009
Last Updated: June 24, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by X-pert Med GmbH:
muscle pain
model

Additional relevant MeSH terms:
Musculoskeletal Pain
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Celecoxib
Ketoprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014