Trial Outcomes & Findings for Placebo In Chronic Back Pain (Phase 2) (NCT NCT02986334)

Last Updated: 2022-11-07

Results Overview

Self-report pain using a VAS scale (0-10) : 0 represents no pain and 10 the worst imaginable pain. Results are presented as percentage (%) change in pain before and after the intervention (baseline and post-intervention, 12 weeks). Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

94 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	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 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). Naproxen: Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening. Omeprazole: 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 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) Placebo: 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.
Overall Study STARTED	14	40	40
Overall Study COMPLETED	11	33	33
Overall Study NOT COMPLETED	3	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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 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). Naproxen: Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening. Omeprazole: 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 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) Placebo: 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.
Overall Study Withdrawal by Subject	0	1	2
Overall Study Lost to Follow-up	1	2	1
Overall Study Adverse Event	0	2	1
Overall Study non compliance in phone ratings	2	1	2
Overall Study undisclosed comorbidities	0	1	1

Baseline Characteristics

Placebo In Chronic Back Pain (Phase 2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Treatment Intervention n=14 Participants 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 Treatment Intervention n=40 Participants 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). Naproxen: Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening. Omeprazole: 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 Treatment Intervention n=40 Participants 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) Placebo: 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.	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants	31 Participants n=4 Participants	33 Participants n=27 Participants	75 Participants n=483 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	9 Participants n=4 Participants	7 Participants n=27 Participants	19 Participants n=483 Participants
Age, Continuous	59.6 years STANDARD_DEVIATION 11.6 • n=93 Participants	58.0 years STANDARD_DEVIATION 10.5 • n=4 Participants	53.0 years STANDARD_DEVIATION 14.3 • n=27 Participants	55.8 years STANDARD_DEVIATION 12.5 • n=483 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	23 Participants n=4 Participants	17 Participants n=27 Participants	49 Participants n=483 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	17 Participants n=4 Participants	23 Participants n=27 Participants	45 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	23 Participants n=4 Participants	25 Participants n=27 Participants	56 Participants n=483 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	16 Participants n=4 Participants	9 Participants n=27 Participants	29 Participants n=483 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants
Region of Enrollment United States	14 participants n=93 Participants	40 participants n=4 Participants	40 participants n=27 Participants	94 participants n=483 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	No Treatment Intervention n=11 Participants 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 Treatment Intervention n=33 Participants 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). Naproxen: Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening. Omeprazole: 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 Treatment Intervention n=33 Participants 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) Placebo: 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.
Percent Change in Pain Assessed by Visual Analogue Scale (VAS)	-0.0145 percentage of pain change Standard Error 0.036	-0.2082 percentage of pain change Standard Error 0.048	-0.1109 percentage of pain change Standard Error 0.050

Adverse Events

No Treatment Intervention

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Active Treatment Intervention

Serious events: 0 serious events

Other events: 16 other events

Deaths: 1 deaths

Placebo Treatment Intervention

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Apkar Vania Apkarian

Northwestern University

Phone: 312-503-0404

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	No Treatment Intervention n=14 participants at risk 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 Treatment Intervention n=40 participants at risk 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). Naproxen: Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening. Omeprazole: 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 Treatment Intervention n=40 participants at risk 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) Placebo: 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.
Metabolism and nutrition disorders pre-diabetic	7.1% 1/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
General disorders Tooth Pain	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
Gastrointestinal disorders GI issues	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
Respiratory, thoracic and mediastinal disorders Shortness of Breath	7.1% 1/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
General disorders Seasonal allergies	7.1% 1/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
General disorders pain following injection	7.1% 1/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
Reproductive system and breast disorders human papillomavirus	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
General disorders Sore throat	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
General disorders Cortisone Shot in Right Hip	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
Eye disorders Cataracts	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
General disorders Cough	7.1% 1/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	5.0% 2/40 • 12 weeks collected at each one of the 6 visits
General disorders Cold	7.1% 1/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	10.0% 4/40 • 12 weeks collected at each one of the 6 visits
Musculoskeletal and connective tissue disorders Cervical Cancer screening	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
Gastrointestinal disorders Flu	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
General disorders High blood pressure	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	5.0% 2/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
General disorders Puncture Bruising	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
Eye disorders Cataract	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
Renal and urinary disorders Kidney Stones	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
Musculoskeletal and connective tissue disorders Hip pain	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
Musculoskeletal and connective tissue disorders Acute pain in left latissimus dorsi	7.1% 1/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
Skin and subcutaneous tissue disorders Body Aches	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
Infections and infestations Acute infection	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
General disorders Molar tooth extraction	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
General disorders Headache	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	5.0% 2/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
Gastrointestinal disorders upset stomach	7.1% 1/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
General disorders Fatigue	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
General disorders Appetite Loss	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
Gastrointestinal disorders Diverticulitis	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
General disorders Cyst removal in left arm	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits
General disorders Right Latissimi dorsi Pain	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
Renal and urinary disorders Urinary Tract Infection	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	5.0% 2/40 • 12 weeks collected at each one of the 6 visits
Gastrointestinal disorders Cystourethroscopy Procedure	7.1% 1/14 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits
Musculoskeletal and connective tissue disorders Left shoulder pain	0.00% 0/14 • 12 weeks collected at each one of the 6 visits	2.5% 1/40 • 12 weeks collected at each one of the 6 visits	0.00% 0/40 • 12 weeks collected at each one of the 6 visits