NCT05275244: NO-DOLOR2

Evaluate Clinical Benefit of Local Treatment With KD Intra-Articular® Gel in Patients With Osteoarthritis (NO-DOLOR2)

Completed Last updated 3 April 2024

What this trial tests

trial testing KD Intra-Articular® gel in Osteoarthritis, Hip in 67 participants. Completed in 14 December 2023.

Timeline

17 March 2022

Primary endpoint
1 September 2022

14 December 2023

Quick facts

Lead sponsor	Procare Health Iberia S.L.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	67
Start date	17 March 2022
Primary completion	1 September 2022
Estimated completion	14 December 2023
Sites	1 location across Spain

Drugs / interventions tested

• KD Intra-Articular® gel

Conditions studied

• Osteoarthritis, Hip — all drugs for Osteoarthritis, Hip →
• Osteoarthritis Thumb — all drugs for Osteoarthritis Thumb →
• Osteoarthritis Ankle — all drugs for Osteoarthritis Ankle →

Sponsor

Procare Health Iberia S.L. — full company profile →

Who can join

18 and older, any sex, with Osteoarthritis, Hip or Osteoarthritis Thumb. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Prospective observational, national, multicentre, open study with a class III medical device with EC marking. Study to evaluate the clinical benefit of local treatment with KD intra-articular® gel in patients with osteoarthritis of the shoulder, hip, ankle or base of the thumb. The study will be conducted in the Rheumatology Service of Spanish Hospitals under the usual medical conditions, in accordance with routine clinical practice and following the internationally recognised precepts of good clinical practice of ICH and Declaration of Helsinki. The objective is to evaluate the evolution of pain in patients diagnosed with single or preferential symptomatic osteoarthritis of the shoulder or hip treated with KD Intra-Articular® gel 2.2% - 44 mg in 2 ml - (Pronolis® HD one 2.2%), and ankle or base of the thumb treated with KD Intra-Articular® gel 1.6% - 16 mg in 1 ml - (Pronolis® HD mini 1.6%).

Eighty patients will be included among about 6 Spanish Sites. The study comprises a maximum of 6 visits per protocol. At visit 0, informed consent will be obtained, the patient will be checked for fulfil the selection criteria. A pain assessment will also be carried out using a Visual Analogue Scale (VAS) and the corresponding questionnaire will be completed depending on the affected joint. According to the usual clinical practice of the site, the study treatment will be administered. A week after the first infiltration the second visit (V1) will be applied, and the VAS will be repeated. The patient's global clinical impression of change will also be assessed, and along with the Likert scale of satisfaction will be collected. The next visit (V2) will be carried out a week after the second infiltration and the procedures will be the same as those of the previous visit (V1). At 4 (V3), 12 (V4) and 24 (V5) weeks after receiving the third infiltration (V2), follow-up visits will be carried out where the assessment procedures will be the same as in visit 0, in addition to the GCI -C, the Likert scale of satisfaction and the collection of potential AEs and changes in concomitant medication. At each visit, the patient will be given a diary, where they will collect the rescue medication they have needed since the previous visit. In the electronic case report form (eCRF), the rescue medication (analgesics and NSAIDs) that you have needed since the previous visit (V0-V2) or in the month prior to the study visit (V3-V6) will be collected.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hydrogels in the clinic: An update.
   Clegg JR, Adebowale K, Zhao Z, Mitragotri S. · · 2024 · cited 64× · PMID 39545079 · DOI 10.1002/btm2.10680