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NCT02013427 · ClinicalTrials.gov registry record · Phase 4
Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 82
- Enrollment target
NCT02013427: Completed Phase 4 study, sponsored by Northwestern University.
NCT02013427 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 82 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02013427, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 82 participants
- Enrollment target
Study Summary
This study is designed to examine brain properties for placebo response in chronic back pain patients. The investigators have preliminary data indicating that, in blinded clinical trial studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can be subdivided into placebo responders and non-responders, and these differences are PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical utility and that its properties can be studied by human brain imaging techniques. In Phase I of the study, the investigators seek to identify brain imaging parameters that predict the propensity for the placebo response in an independent CBP cohort. In Phase II, the investigators will evaluate the interaction between placebo response and medication treatment in individuals stratified as placebo responders versus non-responders. This research is designed to critically assess the neurobiology of placebo analgesia for chronic pain in a partially-blind clinical trial.
Primary Outcome
The primary outcome was changes (% change) in self-reported pain levels using VAS - from 0 (no pain) to 10 (worst imaginable pain). Results are presented as largest percentage (%) change in pain before and after the interventions (baseline and post-intervention, 6 weeks). Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline.
Interventions
- DRUG Placebo
- DRUG Omeprazole
- DRUG Naproxen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-05 |
| Phase | Phase 4 |
What the finished NCT02013427 record still lists
NCT02013427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02013427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02013427 about?
NCT02013427 is a clinical study titled "Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial". This study is designed to examine brain properties for placebo response in chronic back pain patients. The investigators have preliminary data indicating that, in blinded clinical trial studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can be subdivided into pla...
What is the current status of trial NCT02013427?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 82 participants. The study started on 2014-10. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02013427?
The interventions under investigation include: Placebo (DRUG), Omeprazole (DRUG), Naproxen (DRUG).
Who is sponsoring clinical trial NCT02013427?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02013427's enrollment target sits among peer trials
82 939th of 2000 higher than 1,061 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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