Subjects with no spontaneous pain since one month before the enrolment, with hyperalgesia and trophic changes of deep somatic structures from latent algogenic conditions of the lower limbs. MedDRA version: 6.1 Level: SOC Classification code 10028395
Conditions
Interventions
Trade Name: Flectoparin Tissugel
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Diclofenac hydroxyethylpirrolidine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
IBSA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must have signed an informed consent document indicating that they understand the purpose and procedures of the trial, and that they are willing to participate in the trial. Males and non-pregnant, non-lactating females. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control according to the definition of Note 3 of ICH M3 (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner steriliza-tion, abstinence) before entry and throughout the trial. Female subjects must have a negative pregnancy test at screening. Aged between 18 and 65 years. Subjects with no spontaneous somatic pain since at least one month before enrolment. Hyperalgesia in deep somatic structures (latent algogenic condition, e.g., from previous knee microtraumatic events, latent myofascial trigger points) with: a) abnormally low pain threshold of vastus lateralis to electrical stimulation (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects with diagnosis of asthma or any other type of hypersensitivity. Subjects with GI disturbances or disease that in the opinion of the Investigator could be negatively affected by the administration of a NSAID (e.g., gastritis, gastroduodenal ulcer, GI bleeding, etc). Subjects with significant cardiac impairment (i.e. severe heart failure, se-vere ischemic heart disease), history of cerebrovascular disease (i.e. ictus), history of peripheral arterial disease, uncontrolled hypertension (i.e. not stable = repeated measurements of systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg, despite pharmacological treatment). Subjects with any disorder of coagulation and haemostasis that could be negatively affected by the local administration of heparin or diclofenac. Subjects under treatment with any type of analgesic / anti-inflammatory / antirheumatic drug, or with any type of drug that is known to alter the pain threshold by any mechanism. Subjects under treatment with any type of drug affecting haemostasis (e.g., heparin, low molecular weight heparins, oral anticoagulants, mucopolysaccharides, etc). Concomitant use of drugs which may be susceptible to interactions with diclofenac or which may affect safety if used concomitantly (lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs and diuretics). History of significant liver insufficiency or inadequate hepatic function. Subjects with severely impaired renal function. Chronic hepatitis B or C, or HIV, or presence of active hepatitis B or C within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PRIMARY OBJECTIVE: to check whether DHEP Heparin Tissugel is more effective than DHEP Tissugel alone in raising the pain threshold as measured by electrical stimulation (cutis, subcutaneous and muscle), in asymptomatic subjects with hyperalgesia and trophic changes of deep somatic structures from latent algogenic conditions of the lower limbs.;Secondary Objective: SECONDARY OBJECTIVES: a) to check whether DHEP Heparin Tissugel is more effective than DHEP Tissugel alone in raising the pain threshold as measured by mechanical stimulation; b) to check whether DHEP Heparin Tissugel is more effective than DHEP Tissugel alone on trophic changes of subcutis and muscle, in asymptomatic subjects with hyperalgesia and trophic changes of deep somatic structures from latent algogenic conditions of the lower limbs; c) as additional objective, the activity/effectiveness of the three active formulations - DHEP Heparin Tissugel, DHEP Tissugel and Heparin Tissugel - as compared to the placebo formulation will be verified.;Primary end point(s): The primary efficacy endpoint is represented by the pain threshold to electrical stimulation of skin, subcutis and muscle, at the level of the vastus lateralis. | — |
Countries
Italy
Outcome results
None listed