Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: N/A
Brief Summary: Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options have had limited symptomatic effect and are associated with significant side effects. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to have, besides its antidepressant properties, a centrally acting analgesic effect.

The aim of the present study was to investigate the efficacy of duloxetine in reducing pain in older adults with knee OA.

288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary knee OA attending the outpatient clinic of our institution were enrolled in this study. All patients underwent a physical examination and where questioned about the number of flares. Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The primary outcome measure was pain reduction. Secondary outcome measures included improvements in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded. Safety and tolerability were also assessed. Data was collected at baseline and at monthly intervals for 4 months. All staff involved in data collection was blinded to the treatment assignment groups.


Options:
A: Arm Label: Sugar pill; Type: PLACEBO_COMPARATOR; Interventions: Drug: Milnacipran | Arm Label: Milnacipran; Type: ACTIVE_COMPARATOR; Interventions: Drug: Milnacipran | Intervention Type: DRUG; Name: Milnacipran; Assigned to Arm(s): Milnacipran, Sugar pill
B: Arm Label: Duloxetine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Duloxetine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo oral tablet | Intervention Type: DRUG; Name: Duloxetine; Assigned to Arm(s): Duloxetine | Intervention Type: DRUG; Name: Placebo oral tablet; Assigned to Arm(s): Placebo
C: Arm Label: Arm I/Group A (Duloxetine then Placebo); Type: EXPERIMENTAL; Interventions: Drug: duloxetine hydrochloride, Other: placebo | Arm Label: Arm II/Group B (Placebo then Duloxetine); Type: EXPERIMENTAL; Interventions: Drug: duloxetine hydrochloride, Other: placebo | Intervention Type: DRUG; Name: duloxetine hydrochloride; Assigned to Arm(s): Arm I/Group A (Duloxetine then Placebo), Arm II/Group B (Placebo then Duloxetine) | Intervention Type: OTHER; Name: placebo; Assigned to Arm(s): Arm I/Group A (Duloxetine then Placebo), Arm II/Group B (Placebo then Duloxetine)
D: Intervention Type: DRUG; Name: duloxetine HCL; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): N/A

Answer: D