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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.

Study to evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in patients with Osteoarthritis (OA) of the knee

Research Site

A Phase II Randomised, Double-blind, Parallel Group, 4-week treatment, Adaptive Dose Finding, Multi-centre study evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of up to three different oral doses of AZD1386 and Placebo in patients with Osteoarthritis of the knee

The WOMAC pain subscale is a self-administered electronic scale with 5 questions (Walking on flat surface, Going up or down stairs, At night while in bed, Sitting or lying, Standing upright). Responses were recorded on a 50-mm line with 100 units. 0 mm indicated no pain and 50 mm indicated extreme pain. The scores were then converted to a 100-mm scale. WOMAC pain was derived by calculating the mean of the VAS scores from the 5 questions with score scale ranging from 0 to 100, 0 being no pain and 100 extreme pain.

Age Continuous

Gender, Male/Female

Number of Participants Analyzed for the stated measure are defined according to the Modified Intention To Treat analysis set whereas numbers provided in the Participant Flow Module correspond to number of participants enrolled.

Mean of week 2 and week 4 changes from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale, 48 hours recall.

The WOMAC VA 3.1. is a self-administered electronic questionnaire that assesses pain, stiffness and disability related to OA. The Function (daily activities) subscale consists of 17 questions. WOMAC function was derived by calculating the mean of the VAS scores from the 17 questions with scores ranging from 0 to 100, 0 = no difficulty in performing daily activities and 100 = extreme difficulty.

Mean of week 2 and week 4 changes from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale, 48 hours recall.

The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. The Stiffness subscale consists of 2 questions (Severity of stiffness after first awakening in the morning and severity of stiffnes after periods of inactivity later in the day). WOMAC stiffness was derived by calculating the mean of the VAS scores from the 2 questions with score scale ranging from 0 to 100, 0 being no stiffness and 100 extreme stiffness.

Mean of week 2 and week 4 changes from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) stiffness subscale, 48 hours recall.

The WOMAC VA3.1. is a self-administered questionnaire that assesses pain, stiffness and disability related to osteoarthritis. It consists of a pain subscale (5 questions), function subscale (17 questions). and a stiffness subscale (2 questions). The total score was derived by calculating the mean of the VAS scores from all 24 questions with score scale ranging from 0 to 100, 0 being no pain, stiffness and difficulty in performing daily activities and 100 being extreme pain, stiffness and difficulty in performing daily activities.

Mean of week 2 and week 4 changes from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score, 48 hours recall

Overall Study

Patients with past or ongoing intolerability to NSAID´s/COX-2`s or paracetamol/acetaminophen or patients with insufficient pain relief from these treatments were included in the study. The WOMAC pain on walking had to be ≥40 mm and ≤90 mm on a Visual Analogue Scale (VAS) at both enrolment and after 1 weeks wash-out of medication (randomisation)

Arms	Assigned Interventions
Experimental: AZD1386, 90 mg	Drug: AZD1386 oral, during 4 weeks
Experimental: AZD1386, 30 mg	Drug: AZD1386 oral, during 4 weeks
Placebo Comparator: Placebo	Drug: Placebo Oral, during 4 weeks

Study to evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in patients with Osteoarthritis (OA) of the knee - OA19

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Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=368&filename=CSR-D5090C00019.pdf

CSR-D5090C00019.pdf

Trial Results Summaries

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