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

NCT01020279 | Completed Phase 1

• 1 other identifier: XPM-023
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Comparison of the effect of KTG to celecoxib (CE) on muscle pain of the calf caused by eccentric contractions
3. 3.Comparison of the effect of celecoxib (CE) to oral placebo (OP) on muscle pain of the calf caused by eccentric contractions

Conditions

Musculoskeletal Pain

Keywords

muscle pain; model

Outcome Measures

Primary Outcomes (1)

• Pain during muscle contraction

  Day 7

Secondary Outcomes (3)

• Pain during rest

  Day 7

• Surface temperature

  Day 7

• Volume of the lower leg

  Day 7

Study Arms (2)

Parallel Group A

OTHER

Celecoxib 200 mg (Active Comparator) ; Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug)

Drug: Celecoxib, Ketoprofen

Parallel Group B

OTHER

oral Placebo (Placebo Comparator); Ketoprofen in Transfersome® Gel (Experimental); Placebo Gel (Placebo Drug)

Drug: Ketoprofen

Interventions

Celecoxib, Ketoprofen 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.

Parallel Group A

Ketoprofen 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

Parallel Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• X-pert Med GmbH: lead

Study Sites (1)

X-pert Med GmbH

Jena, 07745, Germany

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Myalgia

Interventions

Celecoxib; Ketoprofen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 25, 2009
• Study Start: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: June 28, 2010

Record last verified: 2010-06

Locations

DE (1)