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NCT00763321 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
A Phase 3 study of Chronic Low Back Pain, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 3
- Development phase
- 287
- Enrollment target
- 20
- Study locations
NCT00763321: Completed Phase 3 study of Chronic Low Back Pain, sponsored by AbbVie (prior sponsor, Abbott).
NCT00763321 is a Phase 3 study of Chronic Low Back Pain that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 287 participants, below the 588-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00763321, a Phase 3 study of Chronic Low Back Pain, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 287 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).
Primary Outcome
The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ABT-712
Study Locations (20)
Florida
- Site Reference ID/Investigator# 10060 - Atlantis
- Site Reference ID/Investigator# 10069 - Hollywood
- Site Reference ID/Investigator# 10045 - Kissimmee
- Site Reference ID/Investigator# 10061 - Tampa
Indiana
- Site Reference ID/Investigator# 10053 - Evansville
- Site Reference ID/Investigator# 10055 - Newburgh
- Site Reference ID/Investigator# 10043 - Valparaiso
California
- Site Reference ID/Investigator# 10070 - Burbank
- Site Reference ID/Investigator# 10050 - San Diego
Georgia
- Site Reference ID/Investigator# 10054 - Atlanta
- Site Reference ID/Investigator# 10071 - Marietta
Missouri
- Site Reference ID/Investigator# 10066 - Florissant
- Site Reference ID/Investigator# 10073 - St Louis
Alabama
- Site Reference ID/Investigator# 10044 - Huntsville
Illinois
- Site Reference ID/Investigator# 13604 - Chicago
Kansas
- Site Reference ID/Investigator# 10072 - Prairie Village
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00763321 record still lists
NCT00763321 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, below the 588-participant average among 71 other Chronic Low Back Pain trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Chronic Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00763321 names 20 study sites across 12 states, led by Florida, Indiana, California.
Frequently Asked Questions
What is clinical trial NCT00763321 about?
NCT00763321 is a clinical study titled "Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)". The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).
What is the current status of trial NCT00763321?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 287 participants. The study started on 2008-09. Estimated completion is 2009-04.
What conditions does trial NCT00763321 study?
This clinical trial studies the following conditions: Chronic Low Back Pain.
What interventions are being tested in trial NCT00763321?
The interventions under investigation include: Placebo (DRUG), ABT-712 (DRUG).
Who is sponsoring clinical trial NCT00763321?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00763321 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00763321's enrollment target sits among peer trials
287 17th of 71 higher than 55 of 71 other Chronic Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Low Back Pain 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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