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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The primary aim of this study is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS.
Irritable bowel syndrome (IBS) and, particularly, the pain component of IBS lack effective treatments. Antispasmodics, antidepressants and hypnotherapy have all been proposed for the treatment of pain. Their effectiveness in clinical practice is disappointing, despite meta-analyses suggesting efficacy. The study hypotheses are: that rimegepant will be safe, well-tolerated, and will improve abdominal pain in participants with non-constipation IBS. The primary aim is to evaluate the efficacy of rimegepant on abdominal pain scores in participants with non-constipation IBS. Secondary aims of this study are:
The trial period will consist of a two week run-in period, and 4 week treatment period. Participants will complete a daily diary regarding abdominal pain and stool consistency. They will also complete questionnaires studies of anxiety and depression and IBS-QOL.
An established and validated method using rectal barostat device will be used to measure rectal compliance and sensation. The standard scintigraphic method to measure colonic transit established in the Clinical Research Trials Unit (CRTU) at Mayo Clinic Rochester will be used to evaluate changes in colonic transit.
Anticipated results and Significance: Rimegepant, at doses and mode of administration approved by FDA for the prophylaxis of migraine headache, will be efficacious in the reduction of abdominal pain and rectal sensation in participants with non-constipation IBS and abdominal pain.
This study will provide an early signal of efficacy that may lead to future randomized, controlled trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rimegepant | Experimental |
|
|
| placebo | Placebo Comparator | Placebo ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant 75 MG [Nurtec] | Drug | placebo controlled trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Abdominal Pain Scores | The change in daily abdominal pain scores will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. Total scores range from 0 to 100 with higher scores indicating worse pain. | Baseline; Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bowel Movement Frequency | The change in bowel movement frequency measured by the number of bowel movements a participant reported having each day from baseline through day 28. | Baseline; Day 28 |
| Change in Rectal Compliance |
Not provided
Twenty-four participants with non-constipation IBS and chronic abdominal pain will be recruited for enrollment. Participants will meet specific Rome III IBS diagnostic criteria.
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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39 participants were enrolled in the study, 10 of which were excluded prior to randomization due to screening failing and 5 of which were excluded prior to randomization due to withdrawing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rimegepant |
Rimegepant 75 MG [Nurtec]: placebo controlled trial |
| FG001 | Placebo | Placebo ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days Rimegepant 75 MG [Nurtec]: placebo controlled trial |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rimegepant |
Rimegepant 75 MG [Nurtec]: placebo controlled trial |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Abdominal Pain Scores | The change in daily abdominal pain scores will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score. Total scores range from 0 to 100 with higher scores indicating worse pain. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline; Day 28 |
|
Adverse events were collected from the date the participant received the first dose of medication through the washout period, approximately 56 days.
Adverse events were collected through non-leading questions, signs and symptoms detected during examination, laboratory evaluations, by observations of study personnel and by spontaneous reports from participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rimegepant |
Rimegepant 75 MG [Nurtec]: placebo controlled trial |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retching | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Camilleri, M.D., D.Sc. | Mayo Clinic | 507-266-2305 | camilleri.michael@mayo.edu |
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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 | Dec 11, 2024 | Apr 9, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D010146 | Pain |
| D053560 | Ichthyosis Bullosa of Siemens |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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randomized, double-blind placebo-controlled trial of rimegepant at doses and route of administration approved by the FDA for the prophylaxis of migraine headache.
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concealed allocation; blinded provision of assigned medication through research pharmacy
The change in rectal compliance threshold defined as the change in pressure at half maximum volume (Pr 1/2) measured using a rectal barostat device. The rectal barostat device is a rectal catheter with a polyethylene bag attached (length 22 cm; capacity 600 ml) that is inserted into the rectum and connected to a barostat. The bag is unfolded by inflation with 75 ml of air, followed by complete deflation. After a 10 minute recovery period, the pressure is increased from 0 mmHg in steps of 4 mmHg for 15 seconds per step until 20 mmHg is reached. The observed volume/maximum observed volume will be used to obtain a pressure corresponding to half the maximum observed volume. A calculation of the pressures corresponding to the volumes just above and just below the half maximum volume will provided the specific pressure (Pr 1/2) corresponding to one half of the maximum observed volume.
| Baseline; Day 28 |
| Change in Rectal Sensation Pain Threshold | The change in rectal sensation pain threshold in response to the pressure in the balloon escalating from 0 mmHg to 44 mmHg at 4 mmHg stepwise increases measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their level of pain by indicating a point on the line between each end. That point will be measured from the "unnoticeable" end, and the number of millimeters will be reported as the pain score. Total scores range from 0 to 100 with higher scores indicating worse pain. | Baseline; Day 28 |
| Change in Rectal Sensation Ratings in Response to 24 and 36 mmHg Distensions | The change in rectal sensation ratings in response to 24 mmHg and 36 mmHg distensions measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their sensation of pain, urgency and gas levels by indicating a point on the line between each end. That point will be measured from the "unnoticeable" end, and the number of millimeters will be reported as the pain, gas and urgency scores. Total scores range from 0 to 100 with higher scores indicating worsening sensation of pain, urgency and gas. | Baseline; Day 28 |
| Gastric Emptying of Solids | Percentage of solids moved from the stomach to the small intestine (gastric emptying) at 4 hours on Day 28. | Day 28 |
| Change in Colonic Transit at 24 Hours | The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. | Baseline; Day 28 |
| Colonic Transit at 48 Hours | The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. | Day 28 |
| Irritable Bowel Syndrome Quality of Life | Irritable Bowel Syndrome Quality of Life (IBS-QOL) is a self-reported measure used to assess the impact of irritable bowel syndrome (IBS) on a participant's quality of life. The IBS-QOL consists of 34 items that cover eight distinct sub-domains, including emotional well-being, social functioning, dietary habits and intimate relationships. Each item is rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (a great deal). The raw scores are converted to a 0-100 scale where higher scores indicate a better quality of life. | Baseline; Day 28; Day 56 |
| Number of Participants Who Experienced an Adverse Event | The number of participants who experienced an Adverse Event. | Day 1; Day 28 |
Placebo ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days Rimegepant 75 MG [Nurtec]: placebo controlled trial |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Placebo ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days Rimegepant 75 MG [Nurtec]: placebo controlled trial |
|
|
|
| Secondary | Change in Bowel Movement Frequency | The change in bowel movement frequency measured by the number of bowel movements a participant reported having each day from baseline through day 28. | Posted | Median | Inter-Quartile Range | bowel movements per day | Baseline; Day 28 |
|
|
|
|
| Secondary | Change in Rectal Compliance | The change in rectal compliance threshold defined as the change in pressure at half maximum volume (Pr 1/2) measured using a rectal barostat device. The rectal barostat device is a rectal catheter with a polyethylene bag attached (length 22 cm; capacity 600 ml) that is inserted into the rectum and connected to a barostat. The bag is unfolded by inflation with 75 ml of air, followed by complete deflation. After a 10 minute recovery period, the pressure is increased from 0 mmHg in steps of 4 mmHg for 15 seconds per step until 20 mmHg is reached. The observed volume/maximum observed volume will be used to obtain a pressure corresponding to half the maximum observed volume. A calculation of the pressures corresponding to the volumes just above and just below the half maximum volume will provided the specific pressure (Pr 1/2) corresponding to one half of the maximum observed volume. | Posted | Median | Inter-Quartile Range | mmHg | Baseline; Day 28 |
|
|
|
|
| Secondary | Change in Rectal Sensation Pain Threshold | The change in rectal sensation pain threshold in response to the pressure in the balloon escalating from 0 mmHg to 44 mmHg at 4 mmHg stepwise increases measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their level of pain by indicating a point on the line between each end. That point will be measured from the "unnoticeable" end, and the number of millimeters will be reported as the pain score. Total scores range from 0 to 100 with higher scores indicating worse pain. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline; Day 28 |
|
|
|
|
| Secondary | Change in Rectal Sensation Ratings in Response to 24 and 36 mmHg Distensions | The change in rectal sensation ratings in response to 24 mmHg and 36 mmHg distensions measured using the 100-mm Visual analog scale (VAS). The scale ranges from (unnoticeable) to (unbearable). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "unnoticeable" on the left, and "unbearable" on the right. Participants will identify their sensation of pain, urgency and gas levels by indicating a point on the line between each end. That point will be measured from the "unnoticeable" end, and the number of millimeters will be reported as the pain, gas and urgency scores. Total scores range from 0 to 100 with higher scores indicating worsening sensation of pain, urgency and gas. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline; Day 28 |
|
|
|
|
| Secondary | Gastric Emptying of Solids | Percentage of solids moved from the stomach to the small intestine (gastric emptying) at 4 hours on Day 28. | Posted | Median | Inter-Quartile Range | percentage of solids emptied | Day 28 |
|
|
|
|
| Secondary | Change in Colonic Transit at 24 Hours | The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline; Day 28 |
|
|
|
|
| Secondary | Colonic Transit at 48 Hours | The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken at 4, 6, 8, 24, and 48 hours. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. | Posted | Median | Inter-Quartile Range | units on a scale | Day 28 |
|
|
|
|
| Secondary | Irritable Bowel Syndrome Quality of Life | Irritable Bowel Syndrome Quality of Life (IBS-QOL) is a self-reported measure used to assess the impact of irritable bowel syndrome (IBS) on a participant's quality of life. The IBS-QOL consists of 34 items that cover eight distinct sub-domains, including emotional well-being, social functioning, dietary habits and intimate relationships. Each item is rated on a 5-point Likert scale, ranging from 1 (not at all) to 5 (a great deal). The raw scores are converted to a 0-100 scale where higher scores indicate a better quality of life. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline; Day 28; Day 56 |
|
|
|
|
| Secondary | Number of Participants Who Experienced an Adverse Event | The number of participants who experienced an Adverse Event. | Posted | Count of Participants | Participants | Day 1; Day 28 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Placebo | Placebo ODT appearing identical to the experimental formulation and administered every other day for 4 weeks/30 days Rimegepant 75 MG [Nurtec]: placebo controlled trial | 0 | 12 | 0 | 12 | 3 | 12 |
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Rash | Infections and infestations | Systematic Assessment |
|
| Postural Orthostatic Tachycardia Syndrome | Nervous system disorders | Systematic Assessment |
|
| Change of bowel habit (reduced frequency) | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 | Digestive System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007057 | Ichthyosis |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D007232 | Infant, Newborn, Diseases |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Pain at 24 mmHg |
|
| Gas at 36 mmHg |
|
| Urgency at 36 mmHg |
|
| Pain at 36 mmHg |
|
| 0.019 |
| Superiority |
| Pain at 24 mmHg | ANCOVA | 0.014 | Superiority |
| Gas at 36 mmHg | ANCOVA | 0.027 | Superiority |
| Urgency at 36 mmHg | ANCOVA | 0.051 | Superiority |
| Pain at 36 mmHg | ANCOVA | 0.099 | Superiority |
| Day 56 |
|
| Superiority |
| Day 56 | ANCOVA | 0.26 | Superiority |