Clinical trial NCT00745771: 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
Official title: Multiple Dose, Double-Blind, Double-Dummy, Placebo and Active Controlled Study of Pharmacokinetics of Diractin® as Well as Safety and Efficacy for the Treatment of Muscle Soreness From Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Soreness
Keywords: pharmacokinetics
of Diractin®
safety
efficacy
exercise
Lead sponsor: IDEA AG
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: X-pert Med GmbH
state: Thüringen
Study officials:
affiliation: X-pert Med Jena
name: Egbert Seidel, MD
role: PRINCIPAL_INVESTIGATOR
References: