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A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Self-administered behavioral treatments for Adult Subjects with Symptomatic Irritable Bowel Syndrome (IBS).
EASITx is a pivotal study comparing two self-administered behavioral treatments for irritable bowel syndrome (IBS). The active treatment in EASITx is classified as Software as a Medical Device (SaaMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Arm 1 is an active behavioral treatment for IBS (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD). |
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| Arm 2 | Active Comparator | Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD) | Device | The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Pain Intensity Responder | The primary endpoint of this study is abdominal pain intensity. The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their "worst abdominal pain over the past 24-hours". An Abdominal Pain Intensity Responder is defined as a subject whose daily abdominal pain intensity averaged over the 4 weeks post-treatment (weeks 13 through 16) is at least 30% reduced compared to the daily abdominal pain intensity averaged over the 4 weeks pre-treatment (weeks -4 through -1). | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Pain Intensity | The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their "worst abdominal pain over the past 24-hours". Mean change in reported abdominal pain intensity. | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy Pun, DO | Elevated Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Curebase | San Francisco | California | 94122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12775997 | Background | El-Serag HB. Impact of irritable bowel syndrome: prevalence and effect on health-related quality of life. Rev Gastroenterol Disord. 2003;3 Suppl 2:S3-11. | |
| 23994201 | Background | Ford AC, Bercik P, Morgan DG, Bolino C, Pintos-Sanchez MI, Moayyedi P. Validation of the Rome III criteria for the diagnosis of irritable bowel syndrome in secondary care. Gastroenterology. 2013 Dec;145(6):1262-70.e1. doi: 10.1053/j.gastro.2013.08.048. Epub 2013 Aug 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Arm 1 is an active behavioral treatment for Irritable Bowel Syndrome (IBS) (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD). Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD): The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2020 |
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A Randomized, Double-Blind, Comparator-Controlled, Parallel-Group Study
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| Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) | Device | The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. |
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| Abdominal Pain Frequency | Mean change in reported abdominal pain frequency. The abdominal pain frequency is based on the frequency of abdominal pain measured using a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their "worst abdominal pain over the past 24-hours". Average abdominal pain frequency is defined as the average number of days per week during the 4-week post-treatment assessment period in which the subjects recorded a 1 or greater on the daily pain measurement. Only days during which an assessment is recorded will be included in the calculation of average abdominal pain frequency. Days where severity was >0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days per week in each time period with abdominal pain. A lower score is a better outcome. | Change from baseline (weeks -4 to -1 before treatment) to 4-week post treatment period (Weeks 13-16) |
| Number of Participants With >=30% Improvement in Normal Bowel Movements (Scored as 3, 4, or 5 on the Bristol Stool Form Scale) | Number of Participants with a ≥ 30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fell within Group 2 (normal stools) compared with baseline (Weeks -4 through -1). The result represents the number of participants with ≥ 30% improvement in the percentage of normal stools The BSFS is a visual aid that allows patients to classify their bowel movements into seven groups ranging from a score of 1 (separate hard lumps) to 7 (watery, no solid pieces). The BSFS scores will be grouped as 1,2 (Group 1), 3,4,5 (Group 2) and 6,7 (Group 3). The mid-range bowel movements 3,4 and 5 (Group 2) define normal stools. | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) |
| Daily Stool Frequency | Mean change in reported daily stool frequency Analyses of change in daily stool frequency will only include participants with IBS-C and IBS-D. IBS-C and IBS-D subtypes will be analyzed independently. | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) |
| Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument | The IBS QOL is a 34 item IBS-specific, validated instrument. The 34 items are summed for a total score and then transformed to 0-100 scale with higher scores indicating better IBS specific quality of life. IBS QOL scores will be compared pre- and post-treatment and the mean difference compared by treatment. | Baseline (Week -4) to 4-weeks post-treatment (Week 16) |
| Percent Overall Work Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). Outcomes are expressed as impairment percentages (0-100%) with higher numbers indicating greater impairment and less productivity (worse outcomes). | Baseline (Week -4) to 4-weeks post-treatment (Week 16) |
| Percent Overall Activity Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). Overall activity impairment is based on responses to Question 6. Outcomes are expressed as impairment percentages (0-100%) with higher numbers indicating greater impairment and less productivity (worse outcomes). | 4-weeks post-treatment (Week 16) |
| 12719202 | Background | Leong SA, Barghout V, Birnbaum HG, Thibeault CE, Ben-Hamadi R, Frech F, Ofman JJ. The economic consequences of irritable bowel syndrome: a US employer perspective. Arch Intern Med. 2003 Apr 28;163(8):929-35. doi: 10.1001/archinte.163.8.929. |
| 22426087 | Background | Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15. |
| 21090962 | Background | Mayer EA, Tillisch K. The brain-gut axis in abdominal pain syndromes. Annu Rev Med. 2011;62:381-96. doi: 10.1146/annurev-med-012309-103958. |
| Background | Lackner JM. The role of psychosocial factors in functional gastrointestinal disorders. Quigley, Hongo, Fukuda (eds): Functional and GI Motility Disorders. 2014(33):104-16. |
| 27116612 | Background | Lacy BE, Patel H, Guerin A, Dea K, Scopel JL, Alaghband R, Wu EQ, Mody R. Variation in Care for Patients with Irritable Bowel Syndrome in the United States. PLoS One. 2016 Apr 26;11(4):e0154258. doi: 10.1371/journal.pone.0154258. eCollection 2016. |
| 8218507 | Background | Blanchard EB, Greene B, Scharff L, Schwarz-McMorris SP. Relaxation training as a treatment for irritable bowel syndrome. Biofeedback Self Regul. 1993 Sep;18(3):125-32. doi: 10.1007/BF00999789. |
| 26264539 | Background | Palsson OS. Hypnosis Treatment of Gastrointestinal Disorders: A Comprehensive Review of the Empirical Evidence. Am J Clin Hypn. 2015 Oct;58(2):134-58. doi: 10.1080/00029157.2015.1039114. |
| 29702118 | Background | Lackner JM, Jaccard J, Keefer L, Brenner DM, Firth RS, Gudleski GD, Hamilton FA, Katz LA, Krasner SS, Ma CX, Radziwon CD, Sitrin MD. Improvement in Gastrointestinal Symptoms After Cognitive Behavior Therapy for Refractory Irritable Bowel Syndrome. Gastroenterology. 2018 Jul;155(1):47-57. doi: 10.1053/j.gastro.2018.03.063. Epub 2018 Apr 25. |
| 30473202 | Background | Flik CE, Laan W, Zuithoff NPA, van Rood YR, Smout AJPM, Weusten BLAM, Whorwell PJ, de Wit NJ. Efficacy of individual and group hypnotherapy in irritable bowel syndrome (IMAGINE): a multicentre randomised controlled trial. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):20-31. doi: 10.1016/S2468-1253(18)30310-8. Epub 2018 Nov 23. |
| 12454866 | Background | Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology. 2002 Dec;123(6):2108-31. doi: 10.1053/gast.2002.37095. No abstract available. |
| 25267941 | Background | Yeh VM, Schnur JB, Montgomery GH. Disseminating hypnosis to health care settings: Applying the RE-AIM framework. Psychol Conscious (Wash D C). 2014 Jun;1(2):213-228. doi: 10.1037/cns0000012. |
| 14570733 | Background | Gonsalkorale WM, Miller V, Afzal A, Whorwell PJ. Long term benefits of hypnotherapy for irritable bowel syndrome. Gut. 2003 Nov;52(11):1623-9. doi: 10.1136/gut.52.11.1623. |
| 23617618 | Background | Lowen MB, Mayer EA, Sjoberg M, Tillisch K, Naliboff B, Labus J, Lundberg P, Strom M, Engstrom M, Walter SA. Effect of hypnotherapy and educational intervention on brain response to visceral stimulus in the irritable bowel syndrome. Aliment Pharmacol Ther. 2013 Jun;37(12):1184-97. doi: 10.1111/apt.12319. Epub 2013 Apr 25. |
| 10584162 | Background | Powell RA, Gee TL. The effects of hypnosis on dissociative identity disorder: a reexamination of the evidence. Can J Psychiatry. 1999 Nov;44(9):914-6. doi: 10.1177/070674379904400908. |
| 19711767 | Background | Meyerson J, Konichezy A. Out-of-illness experience: hypnotically induced dissociation as a therapeutic resource in treating people with obstinate mental disorders. Am J Psychother. 2009;63(2):133-46. doi: 10.1176/appi.psychotherapy.2009.63.2.133. |
| 27173407 | Background | Hauser W, Hagl M, Schmierer A, Hansen E. The Efficacy, Safety and Applications of Medical Hypnosis. Dtsch Arztebl Int. 2016 Apr 29;113(17):289-96. doi: 10.3238/arztebl.2016.0289. |
| 9512138 | Background | Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998 Feb;43(2):400-11. doi: 10.1023/a:1018831127942. |
| 10146874 | Background | Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006. |
| 19996233 | Background | Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613. |
| Background | Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol. Clin Res and Reg Affairs, 2010;27(2):42-51 |
| 30728719 | Background | Williamson A. What is hypnosis and how might it work? Palliat Care. 2019 Jan 31;12:1178224219826581. doi: 10.1177/1178224219826581. eCollection 2019. No abstract available. |
| 16316883 | Background | Palsson OS. Standardized hypnosis treatment for irritable bowel syndrome: the North Carolina protocol. Int J Clin Exp Hypn. 2006 Jan;54(1):51-64. doi: 10.1080/00207140500322933. |
| 9299672 | Background | Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203. |
| 22068664 | Background | Palsson OS, Baggish JS, Turner MJ, Whitehead WE. IBS patients show frequent fluctuations between loose/watery and hard/lumpy stools: implications for treatment. Am J Gastroenterol. 2012 Feb;107(2):286-95. doi: 10.1038/ajg.2011.358. Epub 2011 Nov 8. |
| 37391055 | Derived | Berry SK, Berry R, Recker D, Botbyl J, Pun L, Chey WD. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. |
| FG001 | MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. |
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| NOT COMPLETED |
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16 participants in the safety analysis population were excluded from the efficacy analysis population (baseline participants); 8 were excluded for being under age 22 (4 in each treatment group), and 7 participants (4 in the MR group and 3 in the GDH group) did not meet eligibility criteria or experienced technical issues with the Curebase software that prevented study execution. Additionally, 2 participants (1 in each group) were excluded because they did not begin a treatment session.
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| ID | Title | Description |
|---|---|---|
| BG000 | Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Arm 1 is an active behavioral treatment for IBS (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD). Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD): The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment. |
| BG001 | MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline abdominal pain intensity | The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their "worst abdominal pain over the past 24-hours". The daily abdominal pain intensity is the average daily pain intensity over the 4 weeks of phase 1 (weeks -4 through -1) before the start of treatment. | Mean | Standard Deviation | units on a scale |
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| Baseline abdominal pain frequency | Baseline average abdominal pain frequency is defined as the average number of days per week during the 4-week pre-treatment assessment period (Week -4 to -1) in which the subjects recorded a 1 or greater on the daily pain intensity measurement. Only days during which an assessment is recorded was included in the calculation of average baseline abdominal pain frequency. Days where severity was >0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days per week with abdominal pain. | Mean | Standard Deviation | days per week |
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| Baseline IBS-Quality of Life score | The IBS QOL is a 34 item IBS-specific, validated instrument. The 34 item patient responses are summed for a total score and then transformed to 0-100 scale with higher scores indicating better IBS specific quality of life. The IBS QOL questionnaire was completed by patients once at Week -4 prior to treatment and the baseline score calculated based on these responses. | Mean | Standard Deviation | units on a scale |
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| IBS with constipation (IBS-C) | The IBS-C subtype designation is based on a diagnosis by a study physician using Rome IV diagnostic criteria | Count of Participants | Participants |
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| IBS with diarrhea (IBS-D) | The IBS-D subtype designation is based on a diagnosis by a study physician using Rome IV diagnostic criteria | Count of Participants | Participants |
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| IBS with mixed bowel habits (IBS-M) | The IBS-M subtype designation is based on a diagnosis by a study physician using Rome IV diagnostic criteria | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Abdominal Pain Intensity Responder | The primary endpoint of this study is abdominal pain intensity. The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their "worst abdominal pain over the past 24-hours". An Abdominal Pain Intensity Responder is defined as a subject whose daily abdominal pain intensity averaged over the 4 weeks post-treatment (weeks 13 through 16) is at least 30% reduced compared to the daily abdominal pain intensity averaged over the 4 weeks pre-treatment (weeks -4 through -1). | 16 participants in the safety analysis population were excluded from the efficacy analysis population; 8 were excluded for being under age 22 (4 in each treatment group), and 7 participants (4 in the MR group and 3 in the GDH group) did not meet eligibility criteria or experienced technical issues with the Curebase software that prevented study execution. Additionally, 2 participants (1 in each group) were excluded because they did not begin a treatment session. | Posted | Count of Participants | Participants | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) |
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| Secondary | Abdominal Pain Intensity | The Instrument is a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their "worst abdominal pain over the past 24-hours". Mean change in reported abdominal pain intensity. | The analysis population includes all participants with both baseline (weeks -4 to -1 before treatment) and 4-week post treatment period (Weeks 13-16) daily pain scores | Posted | Mean | Standard Deviation | units on a scale | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) |
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| Secondary | Abdominal Pain Frequency | Mean change in reported abdominal pain frequency. The abdominal pain frequency is based on the frequency of abdominal pain measured using a 0-10 numeric rating scale (NRS, 0= no pain, 10= worst pain). The subject is asked daily to record their "worst abdominal pain over the past 24-hours". Average abdominal pain frequency is defined as the average number of days per week during the 4-week post-treatment assessment period in which the subjects recorded a 1 or greater on the daily pain measurement. Only days during which an assessment is recorded will be included in the calculation of average abdominal pain frequency. Days where severity was >0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days per week in each time period with abdominal pain. A lower score is a better outcome. | The analysis population includes all participants with both baseline (weeks -4 to -1 before treatment) and 4-week post treatment period (Weeks 13-16) daily pain scores. | Posted | Mean | Standard Deviation | days/week with abdominal pain | Change from baseline (weeks -4 to -1 before treatment) to 4-week post treatment period (Weeks 13-16) |
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| Secondary | Number of Participants With >=30% Improvement in Normal Bowel Movements (Scored as 3, 4, or 5 on the Bristol Stool Form Scale) | Number of Participants with a ≥ 30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fell within Group 2 (normal stools) compared with baseline (Weeks -4 through -1). The result represents the number of participants with ≥ 30% improvement in the percentage of normal stools The BSFS is a visual aid that allows patients to classify their bowel movements into seven groups ranging from a score of 1 (separate hard lumps) to 7 (watery, no solid pieces). The BSFS scores will be grouped as 1,2 (Group 1), 3,4,5 (Group 2) and 6,7 (Group 3). The mid-range bowel movements 3,4 and 5 (Group 2) define normal stools. | 16 participants in the safety analysis population were excluded from the efficacy analysis population; 8 were excluded for being under age 22 (4 in each treatment group), and 7 participants (4 in the MR group and 3 in the GDH group) did not meet eligibility criteria or experienced technical issues with the Curebase software that prevented study execution. Additionally, 2 participants (1 in each group) were excluded because they did not begin a treatment session. | Posted | Count of Participants | Participants | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) |
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| Secondary | Daily Stool Frequency | Mean change in reported daily stool frequency Analyses of change in daily stool frequency will only include participants with IBS-C and IBS-D. IBS-C and IBS-D subtypes will be analyzed independently. | A total of 115 participants treated with GDH are included in the analysis population: 59 patients had IBS-C and 56 patients had IBS-D. A total of 116 patients treated with MR are included: 59 patients had IBS-C and 57 patients had IBS-D. These numbers are smaller than the total size of the IBS-C and IBS-D populations because not all patients completed the daily diaries for weeks 13 through 16. | Posted | Mean | Standard Deviation | number of bowel movements per day | Baseline score (average of daily score for weeks -4 through -1) was compared to 4-weeks post-treatment (average daily score for weeks 13 through 16) |
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| Secondary | Health-related Quality of Life Using the IBS Quality of Life (QOL) Instrument | The IBS QOL is a 34 item IBS-specific, validated instrument. The 34 items are summed for a total score and then transformed to 0-100 scale with higher scores indicating better IBS specific quality of life. IBS QOL scores will be compared pre- and post-treatment and the mean difference compared by treatment. | Participants that completed the IBS-QoL at Week 16 | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week -4) to 4-weeks post-treatment (Week 16) |
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| Secondary | Percent Overall Work Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). Outcomes are expressed as impairment percentages (0-100%) with higher numbers indicating greater impairment and less productivity (worse outcomes). | Participants who completed the WPAI at Week 16 and who were currently employed (working for pay). | Posted | Mean | Standard Deviation | percentage of impairment | Baseline (Week -4) to 4-weeks post-treatment (Week 16) |
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| Secondary | Percent Overall Activity Impairment Due to IBS Based on the Work Productivity and Activity Impairment (WPAI) Questionnaire | Productivity and absenteeism will be evaluated using the patient reported Work Productivity and Activity Impairment (WPAI) General Health score. The WPAI (Reilly 1993) is a 6-question survey of presenteeism (impairment at work / reduced on-the-job effectiveness) and absenteeism (work time missed). The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS). Overall activity impairment is based on responses to Question 6. Outcomes are expressed as impairment percentages (0-100%) with higher numbers indicating greater impairment and less productivity (worse outcomes). | Participants who completed the WPAI at Week 16 | Posted | Mean | Standard Deviation | percentage of impairment | 4-weeks post-treatment (Week 16) |
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16 Weeks
All adverse events (AEs) will be coded to system organ class (SOC) and preferred terms (PT).
A treatment-emergent AE (TEAE) is defined as an AE that was not present prior to treatment with the investigational digital device, but appeared following treatment or was present at treatment initiation but worsened during treatment.
The frequency of TEAEs will be tabulated by preferred term and system organ class. The maximum severity and frequency of TEAEs will be summarized by treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD | Arm 1 is an active behavioral treatment for IBS (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD). Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD): The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment. | 0 | 188 | 1 | 188 | 6 | 188 |
| EG001 | MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. | 0 | 190 | 0 | 190 | 2 | 190 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Arnold-Chiari malformation | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Dydpepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
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| Panic attack | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Recker, Chief Medical Officer | metaMe Health | 1-888-463-8262 | info@metamehealth.com |
| Dec 24, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019148 | Neuromuscular Blockade |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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The final 4 weeks of the on-treatment period (weeks 9-12) was a pre-specified period for analysis of the primary endpoint measure of abdominal pain due to IBS. An abdominal pain intensity responder was defined as a participant whose daily abdominal pain intensity averaged over the last 4 weeks of phase s (weeks 9 through 12) was at least 30% reduced compared with the daily abdominal pain intensity averaged over the 4 weeks of phase 1. |
| Cochran-Mantel-Haenszel |
| 0.0232 |
| Odds Ratio (OR) |
| 1.76 |
| 2-Sided |
| 95 |
| 1.08 |
| 2.87 |
Odds ratio reflects the odds of the number of GDH responders being greater than the number of MR responders for abdominal pain intensity. |
| Superiority |
| Abdominal pain scores were averaged each week on treatment (1-12) and compared with the average baseline abdominal pain score. Participants that recorded a > 30% decrease in abdominal pain in at least half the weeks on treatment were considered responders. This analysis was specified in FDA Guidance for Industry, "Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment", May 2012. Both the analysis period and the responder threshold (30%) are specified by the FDA Guidance. | Cochran-Mantel-Haenszel | 0.0254 | P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR<>1 adjusting for IBS subtype and gender | Odds Ratio (OR) | 1.76 | 2-Sided | 95 | 1.07 | 2.89 | Odds ratio reflects the odds of GDH being superior to MR. | Superiority | Among all subjects, 64.0% reported Adequate Relief and 67.7% reported overall satisfaction with Regulora. |
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| OG001 | MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. |
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| OG001 | MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. |
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Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. |
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| OG001 | MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. |
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| OG001 | MR-1; Muscle Relaxation, Software as a Medical Device - SaMD | Arm 2 is a behavioral treatment (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD) Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD): The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks. |
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