Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00144820
Status:
UNKNOWN
Last Update Posted:
2005-09-05
First Post:
2005-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 251}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1999-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2001-11'}, 'lastUpdateSubmitDate': '2005-09-02', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain measured on a visual scale on movement (VAS-movement)'}, {'measure': 'At rest (VAS-rest)'}, {'measure': 'During the night (VAS-night)'}], 'secondaryOutcomes': [{'measure': 'KOOS scores (knee injury and osteoarthritis outcome score)'}, {'measure': 'Daily consumption of analgetics'}, {'measure': 'Cartilage and bone degradation markers'}, {'measure': 'The quadriceps circumference (cm), ability to bend (degrees flexion) and stretch (degrees extension) the knee joint'}, {'measure': 'Global assessment patient'}, {'measure': 'Global assessment investigator'}]}, 'conditionsModule': {'keywords': ['Hyaluronan', 'Gonarthrosis', 'Osteoarthritis,knee', 'Double-blinded', 'Placebo controlled', 'Randomised'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '18415773', 'type': 'DERIVED', 'citation': 'Lundsgaard C, Dufour N, Fallentin E, Winkel P, Gluud C. Intra-articular sodium hyaluronate 2 mL versus physiological saline 20 mL versus physiological saline 2 mL for painful knee osteoarthritis: a randomized clinical trial. Scand J Rheumatol. 2008 Mar-Apr;37(2):142-50. doi: 10.1080/03009740701813103.'}]}, 'descriptionModule': {'briefSummary': '251 consecutive patients with knee arthrosis were randomized to one of three interventions: Four weekly injections of 2 ml isotonic saline (placebo), 2 ml sodium hyaluronate (hyaluronan) or 20 ml isotonic saline (excessive saline).\n\nThey all suffered from clinically and radiologically verified arthrosis of the knee with daily pain that did not respond to treatment with analgetics.\n\nResults were evaluated at weeks 1,2,3,4,8,12,16 and 26. Biochemical markers for bone and cartilage degradation were measured in urine/blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, men/women age \\> 60 years with clinical,\n* Radiological and possible arthroscopical verified knee osteoarthritis.\n* Knee pain on the day of examination scoring more than 20 mm on a visual analogue scale (VAS) at baseline.\n\nExclusion Criteria:\n\n* Age below 60\n* Unconsciousness\n* Psychosis\n* Demens\n* Ingestion of drugs that may influence the results of the clinical examinations\n* Inflammatory diseases of the joints\n* Rheumatoid arthritis or other inflammatory arthritis as diagnosed by American College of Rheumatology criteria\n* Contraindication to hyalgan treatment\n* Previous intraarticular fracture of a knee joint\n* Infection or skin disease located at the place of injection and invasive procedures done to the knee joint within previous two months inclusive intra-articular injections of steroids.\n* Any other condition that might interfere with the efficacy assessment or completion of the trial.'}, 'identificationModule': {'nctId': 'NCT00144820', 'briefTitle': 'Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Intra-Articular Injections of Hyaluronan Versus 20 Ml NaCl Versus Placebo in Treatment of Knee Osteoarthritis: a Randomised, Double-Blind, Placebo Controlled Single Centre Trial.', 'orgStudyIdInfo': {'id': 'KA 99005gs'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Injection of Hyaluronan or Saline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen Ø', 'country': 'Denmark', 'facility': 'Copenhagen Trial Unit, H:S Rigshospitalet. dept. 7102', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Charlotte Lundsgaard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen Trial Unit (CTU)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}}}}