Primary Care Study With Chondroitin Sulfate and Glucosamine Hydrochloride in Hand Osteoarhritis (PICASSO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02823548|
Recruitment Status : Unknown
Verified November 2016 by Bioiberica.
Recruitment status was: Recruiting
First Posted : July 6, 2016
Last Update Posted : November 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hand Osteoarthritis||Drug: Droglican Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-blind, Randomised, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of the Combination of Chondroitin Sulphate and Glucosamine Hydrochloride in Patients With Hand Osteoarthritis|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||July 2017|
Patients take one sacchet of Droglican (Chondroitin Sulfate 1,500mg + Glucosamine Hydrochloride 1,200mg) Once a day during 6 months.
Chondroitin Sulfate 1,200mg + Glucosamine Hydrochloride 1,500mg
Placebo Comparator: Placebo
Patients take one sacchet of Placebo once a day during 6 months.
- Huskisson's VAS [ Time Frame: 6 months ]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.
- FIHOA Index [ Time Frame: 6 months ]The FIHOA Index is a semi-quantitative questionnaire administered by the doctor or self-administered by the patient. If necessary, it is the questionnaire can be hetero-administered; investigator can assist the patient in understanding and completing the FIHOA. The questionnaire consists of 10 questions that score between 0 and 3 points (total range of 0-30) assessing the dexterity of the patient suffering from symptomatic Hand Osteoarhritis.
- Changes in grip strength [ Time Frame: 6 months ]
Grip strength in the study hand of the patient will be measured with a dynamometer.
Patients sitting up in a chair supporting straight his/her back, in a position that allows hips and knees are at right angles; They flex the elbow at 90 ° between pronation and supination. Patients will be asked to squeeze the dynamometer as strong as they could according to their individual pain limits. This procedure will be repeated 3 times, with a break of 10 seconds between each of the measurements. The average value of these 3 measurements will be registered as the value for the parameter in the study.
- Duration of morning stiffness [ Time Frame: 6 months ]The time in minutes that it took from the patient waking up in the morning until they felt that joint stiffness in the hand had diminished significantly.
- Patient's global assessment of disease activity [ Time Frame: 6 months ]Patients were asked to quantify their disease status on a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: "Considering all the ways your arthritis of the knee affects you, mark (I) on the scale how well you are doing." Left hand marker "Very Well", Right hand marked "Very Poor".
- Patient's global assessment of response to treatment [ Time Frame: 6 months ]The patient will be asked to score the overall response to the study drug in the hand, placing a vertical line (|) on a 100 mm VAS in the following way: If they mark the left edge (0 mm), it means " none, poor response, ineffective " and if they mark on the right edge (100 mm), it means " excellent, ideal response, virtually pain-free".
- EuroQoL-5D [ Time Frame: 6 months ]
EuroQoL-5D was a standardized instrument for use as a measure of health outcome that provides a simple descriptive profile and a single index value for health status. It was assessed at all of the study visits.
The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Total scale range for each dimension reported is 1 to 3.
The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Total scale range for VAS dimension reported is 0 to 100.
- HAD scale [ Time Frame: 6 months ]The Hospital Anxiety and Depression (HAD) questionnaire aims to determine the emotional state of the patient, as the importance of emotional factors is well-recognised in the majority of diseases. It consists of 14 items, and each item is assigned a score of 0, 1, 2 or 3. The scores are added together and between 0 and 7 means there is no case, between 8 and 10 is a borderline case and scores above 11 are, likely, cases in each one of the sub-scales
- Consumption of Rescue Medication [ Time Frame: 6 months ]
Use of rescue medication as number of paracetamol tablets 500 mg since the last visit. The tablet count was reconciled with the patient diary.
Total Number of pills per month
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823548
|Contact: Marta Herrerofirstname.lastname@example.org|