Primary Care Study With Chondroitin Sulfate and Glucosamine Hydrochloride in Hand Osteoarhritis

NCT02823548 | Unknown Phase 4

• 1 other identifier: DRO/IV-2016-ART-02
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

PICASSO has been designed to demonstrate that combination therapy with CS/GH has superior efficacy compared to placebo in pain reduction (average score reduction in Huskisson's 0 to 100 mm Visual Analogue Scale) from baseline to 6 months of treatment in patients with symptomatic hand osteoarthritis.

Conditions

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Huskisson's VAS

  Huskisson's Visual Analogue Scale of pain. Score Range: 0 (no pain) - 100 (maximum pain) The study was designed such that the outcome of primary interest is hand pain related to OA. The measure selected to best evaluate this is an improvement in the VAS pain.

  6 months

Secondary Outcomes (8)

• FIHOA Index

  6 months

• Changes in grip strength

  6 months

• Duration of morning stiffness

  6 months

• Patient's global assessment of disease activity

  6 months

• Patient's global assessment of response to treatment

  6 months

Study Arms (2)

Droglican

EXPERIMENTAL

Patients take one sacchet of Droglican (Chondroitin Sulfate 1,500mg + Glucosamine Hydrochloride 1,200mg) Once a day during 6 months.

Drug: Droglican

Placebo

PLACEBO COMPARATOR

Patients take one sacchet of Placebo once a day during 6 months.

Drug: Placebo

Interventions

Droglican DRUG

Chondroitin Sulfate 1,200mg + Glucosamine Hydrochloride 1,500mg

Droglican

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 40 years of age;
• Clinical diagnosis of hand osteoarthritis according to ACR criteria;
• Patients who have pain and deformities in at least 2 interphalangeal joints of the studied hand;
• Patients with simple standard anteroposterior X-ray of both hands obtained within the 6 months prior to screening;
• Patients with radiological evidence of hand osteoarthritis grade 2-3 according to the Kellgren-Lawrence radiological scale. Patients must present radiological involvement of at least 2 interphalangeal joints of the studied hand, with or without rhizarthrosis;
• Patients who have had pain in the studied hand most of the days of the month prior to the screening visit;
• Patients with hand pain ≥ 45 mm on Huskisson's Visual Analogue Scale at the screening visit;
• Patients who present a Functional Index of Hand Osteoarthritis (FIHOA) score ≥ 6 at the screening visit;
• 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;
• Patients must have a sufficient level of cognition to allow for proper communication and cooperation with all tests and examinations required in the protocol;
• 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;
• Patients who are not participating in another clinical trial;
• Patients who agree to respect the protocol, attending visits related to the study;

You may not qualify if:

• Patients with isolated unilateral or bilateral rhizarthrosis only and/or radiological evidence of presence of erosive hand osteoarthritis (having just one erosive joint leads to classifying the patient as erosive).
• Patients with a known allergy to CS or GH;
• Patients with a seafood allergy;
• Patients with a history of intolerance to paracetamol;
• Patients with active malignancy of any type or with a history of malignancy in the last five years;
• Patients who, in the investigator's judgement, do not have significant clinical alterations in their physical examination and laboratory parameters;
• 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;
• 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 (involvement 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;
• Pain in other parts of the body more intense than in the hand, which could interfere with the assessment of the joint index;
• Patients with fibromyalgia;
• Patients with surgery scheduled during the clinical trial period;
• 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;
• Patients with poorly controlled diabetes mellitus defined as a level of haemoglobin A1c\> 8%;
• Patients with poorly controlled hypertension (sustained systolic blood pressure ≥160 mm Hg or sustained diastolic blood pressure ≥100 mm Hg);
• Patients with active acute or chronic infections that require antibiotic treatment, or serious fungal or viral infections (for example, hepatitis, herpes zoster, HIV positive);

Sponsors & Collaborators

• Bioiberica: lead

Study Sites (1)

Unknown Facility

Barcelona, Spain

RECRUITING

Central Study Contacts

Marta Herrero

CONTACT

+34934904908; mherrero@bioiberica.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 6, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 11, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)