NCT01455519: Covidien

True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective Double Blind, Placebo-controlled Study of Hydromorphone ER

Completed Phase 4 Results posted Last updated 18 October 2017

What this trial tests

Phase 4 trial testing Hydromorphone ER in Low Back Pain in 51 participants. Completed in 1 December 2014.

Timeline

1 October 2011

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Shirley Ryan AbilityLab
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	51
Start date	1 October 2011
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	1 location across United States

Drugs / interventions tested

• Hydromorphone ER — full drug profile →
• Sugar pill

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

Shirley Ryan AbilityLab — full company profile →

Who can join

18 and older, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in McGill Pain Questionnaire - Short Form
  Time frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
  The McGill Pain Questionnaire - Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).
• Change in VAS
  Time frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
  Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).

Sponsor's own description

You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Opioids compared to placebo or other treatments for chronic low-back pain.
   Chaparro LE, Furlan AD, Deshpande A, Mailis-Gagnon A, et al · · 2013 · cited 135× · PMID 23983011 · DOI 10.1002/14651858.cd004959.pub4