Multiple Dose, Double-Blind, Placebo and Active Controlled Study of Pharmacokinetics of Diractin® as Well as Safety and Efficacy for the Treatment of Muscle Soreness

NCT00745771 | Completed Phase 2

• 1 other identifier: CL-033-II-02
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple-dose, double-blind, double-dummy, parallel, randomized, placebo and active controlled study of pharmacokinetics of Diractin® as well as safety and efficacy for muscle soreness from exercise.

Conditions

Muscle Soreness

Keywords

pharmacokinetics; of Diractin®; safety; efficacy; exercise

Study Arms (2)

1

ACTIVE COMPARATOR

200 mg Ketoprofen

Drug: Diractin

2

ACTIVE COMPARATOR

100 mg Ketoprofen

Drug: Diractin

Interventions

Diractin DRUG

1

Eligibility Criteria

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

You may qualify if:

• 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
• Muscle soreness with a pain score of at least 3 on a 10 point categorical pain scale at 12-16h after exercise
• 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)

You may not qualify if:

• 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 and during the study
• Not willing to refrain from exposing target areas after treatment to excessive ultraviolet light (solar radiation or solarium)
• Pregnancy or lactation
• History of dermal allergic reactions
• 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
• NSAID idiosyncrasy
• Impaired haematopoesis and coagulation
• Gastric and duodenal ulcer and gastrointestinal bleedings
• Systemic lupus erythematodes, mixed connective tissue disease

Sponsors & Collaborators

• IDEA AG: lead

Study Sites (1)

X-pert Med GmbH

Jena, Thuringia, 07745, Germany

Location

MeSH Terms

Conditions

Myalgia; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Egbert Seidel, MD

  X-pert Med Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 3, 2008
• Study Start: October 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 20, 2009

Record last verified: 2009-03

Locations

DE (1)