Randomised, double-blind, multi-centre, placebo-controlled clinical dose finding study in four parallel groups comparing Diclofenac Gel 1 %, Diclofenac Gel 3 %, Diclofenac Gel 5 % and placebo Gel in patients with traumatic blunt soft tissue injury/contusion

ratiopharm GmbH0 个研究点开始时间: 2005年8月23日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Age range 18 - 60 years.
•- Normal general health, with laboratory values within normal range.
•- Injury not older than 3 h prior treatment.
•- Written informed consent.
•- The basic value of the tonometric measurement on the injured site does not exceed 50% of the respective value of the contra-lateral site.
•- The absolute sensitivity to pain on contra-lateral site is at least 2.5 N/sq cm.
•- The size of the traumatisation must be at least 50 sq cm and maximal 150 sq cm
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- History of blood coagulation disorders.
•- History of asthma, COPD, hay fever and swelling of nasal mucosa.
•- Pregnancy or lactation period.
•- Women with childbearing potential without contraceptive methods.
•- Known allergy to ingredients of the study medication.
•- Known hypersensitivity to diclofenac and diclofenac-containing products.
•- Current skin disorders/open wounds in the area to be treated.
•- Gastric and intestinal ulcer.
•- Gastrointestinal, cerebrovascular or other active bleedings.
•- Pre-treatment of injury (any other therapy e.g. previous cooling).
•- Relevant consumption of alcohol on the evening before the study (not more than 0.5l of wine or 1l of beer).
•- Any patient, in the investigators opinion not considered suitable for enrolment.
•- Anticipated poor compliance by the patient.
•- Use of non-steroid anti-inflammatory drugs, analgesics (e.g. acetyl salicylic acid, with the exception of paracetamol) or psychotropic agents in the week before the study.
•- Participation in a clinical study within the previous 30 days.
•- Any relevant surgical treatment during the previous two months or planned during the study.
•- Abuse of alcohol, medicaments or illicit drugs.

发起方