T4P1010 treatment in patients with Osteoarthritic Pain of Knee or Hip
Research type
Research Study
Full title
Validation Study to Investigate the Effect of T4P1010 treatment in Patients with Osteoarthritic Pain of Knee or Hip.
IRAS ID
229355
Contact name
Aliya Asher
Contact email
Sponsor organisation
Tools4Patient
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2017-001028-23, EUDRACT number
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This research study is being conducted by a Sponsor company called “Tools4Patient“. The aim of this research study is to assess the effectiveness of treatment with T4P1010 in managing pain caused by osteoarthritis of the hip or knee when compared to the control group of patients. The study will enrol up to 78 patients into one of two cohorts (ratio 5:1): active group (Cohort 1) or control group (Cohort 2). In the active group, all patients will receive the T4P1010 for 12 weeks as add-on therapy to their regular analgesic therapy (if any). The T4P1010 administered in this study is a placebo made of cornstarch and has been used as the Investigational Medicinal Product during previous studies, T1001-01 and T1001-02. The active group will be informed that they will receive a treatment named T4P1010 and that they may receive a placebo. \n\nAnalysis will also be performed to assess whether patient characteristics and personality traits affect the efficacy of T4P1010. As part of the research study genetic testing will also be performed to assess whether genetic variation alters the pain or its treatment.\n\nFrom screening to end of study, the study duration for each patient will be a maximum 17 weeks, this includes 5 visits to clinic, including a screening visit. Patients in the active group will take one capsule of placebo twice a day during the 12 weeks treatment period, there will be no intake in the control group. This dose regimen will mimic the usual therapy to be taken by patients in osteoarthritis management.\n\nThe aim of this study is to confirm the preliminary data observed during the previous studies on OA patients. This study will increase the robustness of the correlation between patients’ characteristics and placebo response in this population. Once the study will be completed, the patients will be informed during a dedicated Debrief Visit about the nature of the product they took during the study and the scientific purpose of the study.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0421
Date of REC Opinion
28 Sep 2017
REC opinion
Further Information Favourable Opinion