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

Musculoskeletal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020279
• Other study ID #: XPM-023
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2009
• Last updated: June 24, 2010
• Start date: October 2009
• Est. completion date: January 2010

Study information

• Verified date: June 2010
• Source: X-pert Med GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Pain
• Myalgia

Intervention

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.
• 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

Locations

Country	Name	City	State
Germany	X-pert Med GmbH	Jena

Sponsors (1)

Lead Sponsor	Collaborator
X-pert Med GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during muscle contraction		Day 7	No
Secondary	Pain during rest		Day 7	No
Secondary	Surface temperature		Day 7	No
Secondary	Volume of the lower leg		Day 7	No