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

IDEA AG

Status and phase: Completed; Phase 2

Conditions: Muscle Soreness

Treatments: Drug: Diractin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00745771

CL-033-II-02

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 4.2.1 General Exclusion Criteria

  • 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

4.2.2 Medical History Related Exclusion Criteria

• 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
• Major heart disease / uncontrolled hypertension
• Hepatic failure with ALT and/or AST > 2.0 ULN
• Renal failure with serum creatinine levels > 1.5 milligrams/deciliter (mg/dL)
• Varicosis, thrombophlebitis and other vascular disorders of the lower extremities
• Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-sceletal system of the lower limbs
• HIV - Infection
• Hepatitis B or C
• Asthma bronchiale
• Blood donation one month before screening and during study

Trial design

168 participants in 2 patient groups

1

Active Comparator group

Description:

200 mg Ketoprofen

Treatment:

Drug: Diractin

Drug: Diractin

2

Active Comparator group

Description:

100 mg Ketoprofen

Treatment:

Drug: Diractin

Drug: Diractin