Clinical trial where the treatment allocation is made randomly. Neither investigator nor patient will know which of the two possible treatments the patient is actually receiving. The aim of the study is to assess the efficacy and safety of the combination of Chondroitin Sulphate and Glucosamine Hydrochloride in Patients with Hand Osteoarthritis

Phase 1

• Conditions: symptomatic hand osteoarthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-000998-20-ES
• Lead Sponsor: BIOIBÉRICA S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-20
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

1.Men and women ? 40 years of age;
2.Diagnosis of clinical hand osteoarthritis according to ACR criteria (Appendix III);
3.Patients who have pain and deformities in at least 2 interphalangeal joints of the studied hand;
4.Patients with simple standard anteroposterior X-ray of both hands obtained within the 6 months prior to screening;
5.Patients with radiological evidence of hand osteoarthritis grade 2-3 according to the Kellgren-Lawrence radiological scale68. Patients must present radiological involvement of at least 3 interphalangeal joints of the studied hand, with or without rhizarthrosis;
6.Patients who have had pain in the studied hand most of the days of the month prior to the screening visit;
7.Patients with hand pain ? 45 mm on Huskisson's Visual Analogue Scale at the screening visit (Appendix IV);
8.Patients who present a Functional Index of Hand Osteoarthritis (FIHOA) score ? 6 at the secreening visit (Appendix V)55;
9.Women of childbearing age (women whose last menstrual period was more than one year before study enrolment and those who have had tubal ligation or a hysterectomy performed are excluded) must have obtained a negative result for the pregnancy test conducted in the screening phase and must agree to use a medically acceptable contraceptive method throughout the duration of the study. Men participating in the study must also agree to use a medically acceptable contraceptive if they have intercourse with women of childbearing age;
10.Patients must have a sufficient level of cognition to allow for proper communication and cooperation with all tests and examinations required in the protocol;
11.Patients who have been clearly informed of the methods and limitations of the study and agree to sign the informed consent form prior to the conduct of any study procedure and after they;
12.Patients who are not participating in another clinical trial;
13.Patients who agree to respect the protocol, attending visits related to the study;
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 330
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with isolated unilateral or bilateral rhizarthrosis and/or erosive hand osteoarthritis (having just one erosive joint leads to classifying the patient as erosive).
2.Patients with a known allergy to CS or GH;
3.Patients with a seafood allergy;
4.Patients with a history of intolerance to paracetamol;
5.Patients with active malignancy of any type or with a history of malignancy in the last five years;
6.Patients who, in the investigator's judgement, do not have significant clinical alterations in their physical examination and laboratory parameters;
7.History of any condition which, in the investigator's opinion, could lead to misinterpretation of the study results or could pose an additional risk to the patient;
8.Concurrent articular rheumatism (history and/or current presence of signs) that could give rise to an erroneous interpretation of the efficacy on pain or which interfere in its assessment, such as carpal tunnel syndrome, Guyon's canal syndrome (involment of cubital nervous), flexor tenosynovitis, trigger finger, chondrocalcinosis, , aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, rheumatoid arthritis, ankilosing spondylitis, psoriasis, inflammatory bowel disease, connective tissue disease, vasculitis, diabetic neuropathy, post-traumatic osteoarthritis of the finger;
9.Pain in other parts of the body more intense than in the hand, which could interfere with the assessment of the joint index;
10.Patients with fibromyalgia;
11.Patients with surgery scheduled during the clinical trial period;
12.Patients with important diseases or processes, such as psychological or psychiatric disorders or drug consumption which, in the investigator's opinion, is likely to alter the progress of the osteoarthritis or the patient's ability to complete the study;
13.Patients with poorly controlled diabetes mellitus defined as a level of haemoglobin A1c> 8%69;
14.Patients with poorly controlled hypertension (sustained systolic blood pressure ?160 mm Hg or sustained diastolic blood pressure ?100 mm Hg)70;
15.Patients with active acute or chronic infections that require antibiotic treatment, or serious fungal or viral infections (for example, hepatitis, herpes zoster, HIV positive);
16.Patients with chronic liver or kidney disease, defined by AST or ALT levels > 2 times the upper limit of normal (ULN) or blood urea nitrogen (BUN) or serum creatinine levels > 2 times the ULN at the inclusion visit;
17.Patients with a history of alcohol or drug consumption or abuse in the last 3 years;
18.Patients who have received any investigationa drug in the 30 days prior to the secreening visit;
19.Women who are breastfeeding;
20.Patients who are receiving lithium carbonate, phenytoin or anti-coagulants, such as warfarin (with the exception of ASA up to a maximum daily dose of 100 mg);

Study & Design

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