NCT00376311

Effects of Oral Salmon Calcitonin in Human Osteoarthritis

Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (planned)
• Sponsor: Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis

Detailed description

Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability. Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA. Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	oral salmon calcitonin

Timeline

• Start date: 2002-09-01
• Completion: 2004-05-01
• First posted: 2006-09-14
• Last updated: 2006-09-14

Locations

1 site across 1 country: Belgium