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NCT01200069 · ClinicalTrials.gov registry record · Phase 4
IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia
A Phase 4 study, sponsored by Rutgers, The State University of New Jersey.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT01200069 is a Phase 4 study that was terminated before completion, run by Rutgers, The State University of New Jersey. The registered enrollment target is 14 participants.
The verdict
NCT01200069, a Phase 4 study, was terminated before completion, sponsored by Rutgers, The State University of New Jersey.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
Post-procedure myalgia (muscle ache) is a well-known and common complication of Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in approximately 50% of these cases. The pain is usually described as muscle soreness, similar to that resulting from strenuous exercise. The myalgias typically begin shortly after the procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of patients considered prevention significant and would be willing to pay a median of $33 out of pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a further financial burden if these patients are unable to return to work or resume previous daily activities in the days following the procedure. An agent that could treat and possibly even prevent these myalgias has the potential to be very beneficial to these patients. IV ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an adjunct to opioid analgesics, and for the reduction of fever.
Interventions
- DRUG Placebo infusion
- DRUG ibuprofen intravenous
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01200069
The ClinicalTrials.gov registry entry for NCT01200069 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo infusion is the first listed.
NCT01200069 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01200069 about?
NCT01200069 is a clinical study titled "IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia". Post-procedure myalgia (muscle ache) is a well-known and common complication of Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in approximately 50% of these cases. The pain is usually described as muscle soreness, similar to that resulting from strenuous exe...
What is the current status of trial NCT01200069?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2010-07. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01200069?
The interventions under investigation include: Placebo infusion (DRUG), ibuprofen intravenous (DRUG).
Who is sponsoring clinical trial NCT01200069?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
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