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/contusio

• Conditions: Male or female ambulant patients (age range 18-60 years) suffering from fresh impact injuries (traumatic blunt soft tissue injury/contusion). Time elapse between traumatic event and inclusion must not be longer than 3 hours.; Level: PTClassification code 10022117

• Registration Number: EUCTR2005-000888-26-DE
• Lead Sponsor: ratiopharm GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this study is to investigate the dose response relationship of Diclofenac Gel 1%, Diclofenac Gel 3% and Diclofenac Gel 5% in patients with traumatic blunt soft tissue injury/contusion in comparison with placebo as assessed by speed of decrease in pain intensity.;Primary end point(s): The primary objective is the area under the curve ( AUC) of the tonometric pain-measurement (pain-time curve) over 3 days (Day1, 2 and 3).;Secondary Objective: - Dose-response relationship.<br>- Time to resolution of pain.<br>- Pain assessment by visual analogue scales (VAS), at rest and on movement by patient.<br>- Ratio of tenderness values (injured site/contra-lateral site).<br>- Tonometric pain-measurement (pain-time curve; AUC) over the whole time<br>(7 days).<br>- Consumption of rescue medication (paracetamol).<br>- Global assessment of efficacy by investigator and patient.<br>- Sum of pain intensity difference (SPID).<br>