Post-surgical pain in subjects undergoing one of the following minor orthopaedic interventions: arthroscopic meniscectomy, arthroscopic removal of bone fragments, surgical correction of hallux valgus
Conditions
Interventions
Product Name: DICLOFENAC sodium Hydroxypropyl-beta-cyclodextrin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Diclofenac
Concentration unit: µg/ml microgram(s)/millilitre
Concentrat
Sponsors
IBSA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult males and females in-patients aged ≥ 18 to ≤ 65 years; Subjects able and willing to give their written informed consent; Subjects undergoing one of the following minor orthopaedic interventions: arthroscopic meniscectomy, arthroscopic removal of bone fragments, surgical correction of hallux valgus; Presence of moderate to severe post-operative pain, defined as a level of at least 50 mm measured on a 0-100 mm visual analogue scale; Pain attack started not more than 6 hours from surgery; Physical examination results, including vital signs, within the reference ranges or without clinically significant abnormalities as judged by the Investigator; Preoperative laboratory tests (haematology, blood chemistry, urinalysis) performed within 2 weeks before V1, and instrumental tests (e.g. X rays, ECG), in the reference ranges or without clinically significant abnormalities as judged by the Investigator; Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) and must be willing to continue using it throughout the entire study period; Female subjects of childbearing potential must have a negative urine pregnancy test at the baseline visit. 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
Exclusion criteria: Evidence of systemic infection or infection at the site of operation; Complications occurring after the surgical procedure; Patients with clinical signs of or known gastro-duodenal ulcer; Patients with clinical signs or history of coagulation disorders, or with a history of recurrence ulceration or gastrointestinal bleeding; Alcohol or drug abuse < 1 year; Presence or intention of pregnancy and breast feeding; Patients with known hypersensitivity to Diclofenac or to other NSAID drugs, or to one of the components of the preparation; Patients under chronic treatment with topical or systemic analgesics/NSAIDs; Prior intake of systemic NSAIDs or analgesics in the 12 hours before surgery, opioids in the 7 days before surgery, or corticosteroids (by any administration route) in the 60 days before surgery; 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, steroids and diuretics); Clinically significant or unstable concurrent diseases whose sequeleae or treatment might interfere with the study evaluation parameters; Patients with hepatic impairment; renal impairment or heart failure (of any degree); Patients with metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the investigator, could compromise the patient?s participation in the study; Patients who have used any investigational drug/device and/or participated in any clinical trial in the previous 3 months; Patients who have been previously enrolled in this study; Patients unable to give a valid informed consent; Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that Diclofenac HPBCD s.c. is better tolerated than Voltaren i.m. in terms of local tolerability at the site of injection.;Secondary Objective: The secondary objectives of the study are: To compare the local tolerability of Diclofenac HPBCD i.m. with that of Diclofenac HPBCD s.c. and Voltaren i.m. To assess the analgesic efficacy of the three investigational medicinal products. To assess the general safety of the three investigational medicinal products as regards frequency of adverse events, laboratory parameters (haematology, blood chemistry, urinalysis) and vital signs (heart rate and blood pressure). To determine the amount of hydroxyl-propyl-β-cyclodextrin excreted in urine following both s.c. and i.m. administration of the tested product in a subset of approximately 12 patients.;Primary end point(s): The primary endpoint of the study will be the assessment of local tolerability at the injection site (presence of persistent redness, presence of persistent swelling, presence of hardening) as assessed by the investigator at 10, 30, 60, 90 minutes and at 3, 6 and 12-18 hours after the first drug administration by means of a 4-point severity scale (where 0 = none, 1 = mild, 2 = moderate, 3 = severe). The mean value of the measurements carried out at any time point will be the primary variable of the study. The overall score will range from 0 to 9. | — |
Countries
Italy
Outcome results
None listed