Efficacy and Safety of Vibrant Capsule vs. Placebo for the Treatment of Chronic Idiopathic Constipation

Chronic Idiopathic Constipation Clinical Trial

— Vibrant  

Official title:

A Prospective, Randomized, Multi-center, Double-Blinded, Placebo-Controlled, 3-Arm Clinical Study to Assess the Efficacy and Safety of Vibrant Capsule, for the Treatment of Chronic Idiopathic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879239
• Other study ID #: 270CLD
• Status: Completed
• Phase: N/A
• Start date: March 30, 2019
• Est. completion date: January 5, 2022

Study information

• Verified date: December 2022
• Source: Vibrant Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective, randomized, multicenter, adaptive design, double blinded, placebo-controlled study, to evaluate the efficacy and safety of Vibrant Capsule vs. placebo in relieving constipation in subjects with Chronic Idiopathic Constipation.

Description:

Subjects came for 4 visits: Screening (visit 1), baseline (visit 2), after 4 treatment weeks from baseline (visit 3) and after 8 treatment weeks from baseline (Final visit , visit 4). A total of 8 treatment weeks Three arms were assessed: - Vibrant Capsule mode A administered 5 times per week - Vibrant Capsule mode B administered 5 times per week - Placebo Capsule administered 5 times per week The difference between the 2 operating modes is in the vibrating sequence during the capsule's operating time. Following Interim Analysis one active arm was dropped and the study continued with 2 arms, placebo and an active arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: January 5, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Subjects aged 22 years and older

2. Subjects with Chronic Idiopathic Constipation (CIC) according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives used for at least one month at recommended dose)

3. Subjects with an average of =2.5 Spontaneous Bowel Movements (SBM) per week and =1 SBM per week

4. Normal colonoscopy performed within 5 years prior to study participation, unless the subjects are <50 years old and without alarm signs and/or symptoms

5. Subject signed the Informed Consent Form (ICF)

6. Female subjects must have a negative blood pregnancy test during screening, confirmed by a negative urine pregnancy test during baseline and must not be lactating prior to receiving study medication. For females of child-bearing potential, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. All other female subjects must have the reason for their inability to bear children documented in the medical record [i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)]; in these circumstances, a pregnancy test will not be necessary Exclusion Criteria: History of complicated/obstructive diverticular disease 2. History of intestinal or colonic obstruction, or suspected intestinal obstruction.

3. History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission) 4. History of gastroparesis 5. Use of any of the

following medications:

• Medications that may affect intestinal motility, prokinetics, anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium hydroxide
• With the exception of antidepressants, thyroid or hormonal replacement therapy, when the subject has been on a stable dose for at least 3 months prior to enrollment.

6. Clinical evidence of significant respiratory, cardiovascular, renal, hepatic, biliary, endocrine, psychiatric or neurologic disease 7. Presence of cardiac pacemaker or gastric electrical stimulator. 8. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.

9. Diagnosis of mega-rectum or colon, congenital anorectal malformation, clinically significant rectocele, history of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit 10. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia 11. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study 12. Subjects with pelvic floor dysfunction/defecatory disorder, based on subject history 13. Participation in another clinical study within one month prior to screening.

14. Women who are pregnant or lactating 15. Use of any medication for constipation relief during the study, except as rescue medication, as indicated by study rules 16. Inability to use an electronic daily Diary (on a computer, phone application, tablet or other electronic device) to report bowel movements, symptoms and medication usage

17. Subject participated in a previous Vibrant study 18. Subjects planning to undergo MRI during the study 19. Any known allergy to soybean or beeswax or Calcium Carbonate

20. Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Device:
• Vibrating capsule
Vibrating Capsule administered 5 times per week

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	Great Lakes Medical Research LLC	Beachwood	Ohio
United States	G & L Research, LLC.	Foley	Alabama
United States	PharmQuest	Greensboro	North Carolina
United States	Clinical Inquest Center Ltd	Huber Heights	Ohio
United States	Clinical Neuroscience Solutions dba CNS Healthcare	Memphis	Tennessee
United States	Great Lakes Gastroenterology Research	Mentor	Ohio
United States	Del Sol Research Management	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vibrant Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CSBM1	CSBM1 success rate when using the data from the two active arms together	8 weeks of treatment
Other	CSBM2	CSBM2 success rate when using the data from the two active arms together	8 weeks of treatment
Other	SBM	SBM success rate, defined as number of subjects with an increase from baseline period of at least one weekly Spontaneous Bowel Movement (SBM) during at least 6 of the 8 weeks of treatment	8 weeks of treatment
Other	Rescue	The number of incidence of Rescue Medication use during the treatment period	8 weeks of treatment
Other	Change in SBM	Change from baseline in weekly number of Spontaneous Bowel Movement (SBM)	8 weeks of treatment
Other	SBM after firs dose	Number of subject with SBM during the first 24 hours after first dose in all 3 arms	8 weeks of treatment
Other	Abdominal gas using VAS score (0-10) where 0=No abdominal gas and 10=Unbearable abdominal gas	Change from baseline in average abdominal gas in all 3 arms	8 weeks of treatment
Other	Abdominal pain using VAS scale (0-10) for Pain , where 0=no pain and 10= Unbearable pain	Change from baseline in average abdominal pain in all 3 arms	8 weeks of treatment
Other	Abdominal discomfort using VAS scale (0-10) where 0= no discomfort and 10 = Unbearable discomfort	Change from baseline in abdominal discomfort in all 3 arms	8 weeks of treatment
Other	Time to occurrence	Time to occurrence of spontaneous bowel movement after first capsule activation	8 weeks of treatment
Other	TSQM - scale is 0-100 . where 0 is not satisfied and 100 is very satisfied	Treatment satisfaction score using the TSQM (Treatment Satisfaction Questionnaire for Medication)	8 weeks of treatment
Other	PAC-QOL - scale is 0-100 . where 0 is not constipated and 100 is very constipated	Change from baseline in quality of life using the PAC-QOL (Patient Assessment of Constipation Quality of Life) questionnaire	8 weeks of treatment
Primary	CSBM1 & CSBM2 Success Rate	defined as number of subjects with an increase from the run-in period of at least one weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment, and CSBM2 success rate, defined as number of subject with an increase from the run-in period of at least two weekly Complete Spontaneous Bowel Movement (CSBM) during at least 6 of the 8 weeks of treatment.; The study will be deemed successful if either the CSBM1 or the CSBM2 success rate is statistically significantly higher in the active arm that was continued after the interim analysis, than in the placebo arm; NOTE: A spontaneous bowel movement (SBM) is defined as a bowel movement that occurs at least 48h after laxative/rescue intake and without digital maneuver.; A complete spontaneous bowel movement (CSBM) is defined as a spontaneous bowel movement associated with a feeling of complete evacuation by the subject.	8 weeks of treatment
Primary	Adverse event	Safety endpoints include all adverse events related and unrelated to the study treatment in all 3 arms	up to 11 weeks
Secondary	straining using VAS scale (0-10) for straining where "0" is no straining and "10" is unbearable straining	Change from baseline in average straining in all 3 arms	8 weeks of treatment
Secondary	consistency using the bristol stool scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass) and 7 =watery, no solid pieces, entirely liquid	Change from baseline in average stool consistency, using the Bristol Stool Scale in all 3 arms	8 weeks of treatment
Secondary	bloating sing VAS scale (0-10) for bloating where 0=No bloating and 10=Unbearable bloating	Change from baseline in average bloating in all 3 arms	8 weeks of treatment