Placebo In Chronic Back Pain (Phase 2) (PICP2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02986334|
Recruitment Status : Unknown
Verified December 2016 by Apkar Apkarian, Northwestern University.
Recruitment status was: Recruiting
First Posted : December 8, 2016
Last Update Posted : December 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Drug: Naproxen Drug: Omeprazole Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Brain Mechanisms For Clinical Placebo in Chronic Pain: A Randomized Clinical Trial of Placebo, Active Treatment, and No Treatment in Chronic Back Pain|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2018|
No Intervention: No Treatment Intervention
Observational Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment.
Active Comparator: Active Treatment Intervention
Naproxen & Omeprazole Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).
Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening.
Subjects enrolled in the active treatment arm will receive 20mg of Omeprazole prescribed twice daily, once in the morning and evening. Furthermore, subjects should take this one hour before a meal.
Placebo Comparator: Placebo Treatment Intervention
Subjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo capsules twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment)
Subjects enrolled in the inactive treatment arm will receive two prescriptions, however, there are no active ingredients and are intended to look identical to the active treatment. Therefore, subjects will be instructed exactly the same way as if they were ingesting the active treatment.
Other Name: Sugar Pill
- VAS pain scale [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986334
|Contact: Taha B Abdullah, M.S.||firstname.lastname@example.org|
|United States, Illinois|
|Northwestern University Feinberg School of Medicine||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Taha B Abdullah, M.S. 312-451-8468 email@example.com|
|Principal Investigator:||Apkar V Apkarian, PhD||Northwestern University Feinberg School of Medicine|