Trials / Terminated
TerminatedNCT01087203
A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the effectiveness and safety of the investigational drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.
Detailed description
This study was terminated on 18 November 2010 following a US FDA clinical hold for the tanezumab diabetic peripheral neuropathy clinical study which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tanezumab | 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8) |
| BIOLOGICAL | placebo | Placebo to match tanezumab 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8) |
Timeline
- Start date
- 2010-03-30
- Primary completion
- 2010-11-18
- Completion
- 2011-07-06
- First posted
- 2010-03-16
- Last updated
- 2021-02-24
- Results posted
- 2021-02-24
Locations
48 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01087203. Inclusion in this directory is not an endorsement.