NCT00944697

Brief Summary

To show superior analgesic efficacy of OXN PR in addition to a patient's current dose of pregabalin compared to pregabalin alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 28, 2012

Completed
Last Updated

August 17, 2012

Status Verified

August 1, 2012

Enrollment Period

8 months

First QC Date

July 22, 2009

Results QC Date

November 22, 2011

Last Update Submit

August 9, 2012

Conditions

Moderate to Severe Pain Due to Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (1)

  • Short Form McGill Pain Score.

    The McGill Pain Score is the sum of the answers to three questions: A - describe your pain during the last week, 15 descriptors, (from 0 to 45 total), B - rate your pain during the last week (from 0 to 100), C: present pain intensity (0 to 5). Total pain score will be out of 150, with 0 being least pain and 150 being most pain.

    Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)

Study Arms (2)

Tablets

PLACEBO COMPARATOR

A placebo tablet to match the active reference treatment

Drug: Placebo tablets

Tablet

ACTIVE COMPARATOR

Oxycodone Naloxone tablets

Drug: Oxycodone Naloxone

Interventions

Oxycodone NaloxoneDRUG

Oxycodone Naloxone tablets

Tablet
Placebo tabletsDRUG

Placebo Oxycodone Naloxone tablets

Tablets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe pain due diabetic polyneuropathy
  • Opioid-naive subjects

You may not qualify if:

  • Females who are pregnant or lactating
  • Subjects with evidence of significant structural abnormalities of the gastrointestinal tract
  • Subjects with evidence of impaired liver/kidney function upon entry into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Oliver Emrich

Ludwigshafen, 67069, Germany

Location

Related Links

MeSH Terms

Interventions

oxycodone naloxone combination

Results Point of Contact

Title
Director of Medical Operations
Organization
Mundipharma Research GmbH
info@contact-clinical-trials.com
44 01223424900

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 23, 2009

Study Start

July 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

August 17, 2012

Results First Posted

February 28, 2012

Record last verified: 2012-08

Locations

DE(1)