NCT01882543

Efficacy and Safety of AQX-1125 in IC/BPS

A Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Mediated by the Src Homology-2-domain-containing Inositol 5' Phosphatase [SHIP1] Pathway

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Aquinox Pharmaceuticals (Canada) Inc. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of 6 weeks of treatment with once daily administration of AQX-1125 compared to placebo on average daily pain in subjects with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary

Conditions

• Interstitial Cystitis
• Bladder Pain Syndrome

Interventions

Type	Name	Description
DRUG	AQX-1125	Synthetic SHIP1 activator
DRUG	Placebo	Double blind placebo capsule

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-06-20
• Last updated: 2017-09-05
• Results posted: 2017-09-05

Locations

29 sites across 2 countries: United States, Canada