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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study is being done to see if Lyrica helps people with irritable bowel syndrome.
Lyrica is the trade name for pregabalin, which was first approved by the FDA in June 2005 and has been available through prescription since fall 2005, and is marketed by Pfizer. Lyrica is known to have clinical efficacy treating pain disorders including irritable bowel syndrome-related conditions such as fibromyalgia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Active Comparator | Subjects randomized to this arm will receive the following dosage: 75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study. |
|
| Placebo | Placebo Comparator | Subjects randomized to this arm will receive placebo matching the study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | weeks 9-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. |
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Inclusion Criteria:
Exclusion Criteria:
Known alternative/concurrent gastrointestinal diagnosis (e.g. Crohn's disease, ulcerative colitis, microscopic colitis, active celiac sprue, chronic pancreatitis or pancreatic insufficiency, scleroderma, chronic intestinal pseudo-obstruction, bacterial overgrowth, recent (<6 months) intestinal bacterial/protozoal/ parasitic infections, HIV, active pelvic floor dysfunction, paraplegia or quadriplegia);
Current symptoms of severe depression, as measured by Hospital Anxiety and Depression Scale (HADS) score (greater or less than 15);
Mental retardation or any condition requiring a legal guardian;
Current or past history of psychotic disorder (schizophrenia, bipolar disorder)
Recent or current use (within past 30 days) of drugs that interact with Pregabalin:
Rosiglitazone (Avandia) or Pioglitazone (Actos)
Narcotic anti-pain medications (e.g. oxycodone, morphine)
Anti-anxiety medications (e.g. lorazepam, alprazolam, diazepam)
Unable to withdraw medications at least 72 hours prior to the study, because we will evaluate patient's response to pregabalin therapy for relief of IBS-associated pain and disturbed sleep.
Planned surgery (especially transplant) or anesthesia exposure during trial
Are pregnant, lactating, likely to become pregnant during medication phase and not willing to use a reliable form of contraception (barrier contraceptives, diaphragm, injections, intrauterine device, surgical sterilization, or abstinence)
Recent or current use (within 30 days) of Pregabalin
Known allergy to Pregabalin
Significant acute or chronic progressive neurologic, hepatic, renal, cardiovascular, respiratory or metabolic disease
Recent history of alcohol or substance dependence use or abuse
Another household member or relative participating in the study
Professional drivers or operators of heavy machinery
Major cardiovascular events in the last 6 months
Use of IBS-specific drugs such as tegaserod (Zelnorm) and Lotronex (Alosetron) (within 30 days)
Participation in another clinical trial (within 30 days)
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| Name | Affiliation | Role |
|---|---|---|
| Yuri A Saito Loftus, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States | ||
| Mayo Clinic Health System - Franciscan Healthcare in La Crosse |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Subjects randomized to this arm will receive the following dosage: 75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study. Pregabalin: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study. |
| FG001 | Placebo | Subjects randomized to this arm will receive placebo matching the study drug. Placebo: A matching placebo will be administered twice a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Subjects randomized to this arm will receive the following dosage: 75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Pain Bowel Symptom Scale (BSS) Score Over Last 4 Weeks of Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Intent to treat analysis | Posted | Mean | Standard Deviation | units on a scale | weeks 9-12 |
|
1 year
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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 | Pregabalin | Subjects randomized to this arm will receive the following dosage: 75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| External Trauma | Social circumstances | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuri A. Saito Loftus, M.D. | Mayo Clinic | 507-284-2687 | saito.yuri@mayo.edu |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
|
| Placebo | Drug | A matching placebo will be administered twice a day |
|
| weeks 9-12 |
| Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Weeks 9-12 |
| Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Weeks 9-12 |
| Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Weeks 9-12) |
| Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy | One of the weekly questions asked of subjects was, "Did you have adequate relief of your IBS symptoms over the last week?" Possible answers were Yes or No. | Weeks 9-12 |
| Mean Pain BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Week 12 |
| Mean Overall Severity BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Week 12 |
| Mean Constipation BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Week 12 |
| Mean Diarrhea BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Week 12 |
| Mean Bloating BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Week 12 |
| Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | baseline, week 12 |
| La Crosse |
| Wisconsin |
| 54601 |
| United States |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Nonadherence |
|
| BG001 | Placebo | Subjects randomized to this arm will receive placebo matching the study drug. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Subjects with Fibromyalgia at Baseline | Number | participants |
|
| OG001 | Placebo | Subjects randomized to this arm will receive placebo matching the study drug. |
|
|
|
| Secondary | Mean Overall Severity of Irritable Bowel Syndrome (IBS) Symptoms BSS Score Last 4 Weeks of the Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | weeks 9-12 |
|
|
|
|
| Secondary | Mean Constipation BSS Score Over Last 4 Weeks of Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Weeks 9-12 |
|
|
|
|
| Secondary | Mean Diarrhea BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Weeks 9-12 |
|
|
|
|
| Secondary | Mean Bloating BSS Score Over the Last 4 Weeks of the Study (Weeks 9-12) | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Weeks 9-12) |
|
|
|
|
| Secondary | Number of Subjects With Adequate Relief of IBS Symptoms at Least 50% of the Last 4 Weeks of Therapy | One of the weekly questions asked of subjects was, "Did you have adequate relief of your IBS symptoms over the last week?" Possible answers were Yes or No. | Intent to treat analysis | Posted | Number | participants | Weeks 9-12 |
|
|
|
|
| Secondary | Mean Pain BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
|
| Secondary | Mean Overall Severity BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
|
| Secondary | Mean Constipation BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
|
| Secondary | Mean Diarrhea BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
|
| Secondary | Mean Bloating BSS Score at Week 12 | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | The analysis population is different than the participant flow because some subjects didn't return for a follow-up visit, or didn't complete the questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
|
| Secondary | Number of Subjects With Greater Than or Equal to a 30 Point Change in Pain BSS Score | The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. | Intent to Treat analysis | Posted | Number | participants | baseline, week 12 |
|
|
|
|
| 1 |
| 41 |
| 28 |
| 41 |
| EG001 | Placebo | Subjects randomized to this arm will receive placebo matching the study drug. | 0 | 44 | 24 | 44 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Tired | General disorders | Systematic Assessment |
|
| Pain in lower chest | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cramping right side | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Dizzy | Nervous system disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | Systematic Assessment |
|
| Flu like symptoms | Infections and infestations | Systematic Assessment |
|
| Heart racing | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Mucus in bowel movement | Gastrointestinal disorders | Systematic Assessment |
|
| Weight gain | General disorders | Systematic Assessment |
|
| Restless at night | General disorders | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Body aches | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Abdominal gas | Gastrointestinal disorders | Systematic Assessment |
|
| Stress | General disorders | Systematic Assessment |
|
| Feeling of being high or tipsy | Nervous system disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Paresthesia (tingling) of the fingers | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fullness in the abdomen | Gastrointestinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itch | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Leg cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Burping | Gastrointestinal disorders | Systematic Assessment |
|
| Dry eyes | Eye disorders | Systematic Assessment |
|
| More bowel movements than usual | Gastrointestinal disorders | Systematic Assessment |
|
| Loss of appetite | Gastrointestinal disorders | Systematic Assessment |
|
| No libido | Reproductive system and breast disorders | Systematic Assessment |
|
| Pain in upper right chest | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Excessive thirst | Gastrointestinal disorders | Systematic Assessment |
|
| Blood pressure increased | Cardiac disorders | Systematic Assessment |
|
| Muscle pain rib cage right side | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain over all body | General disorders | Systematic Assessment |
|
| Pain lower left side | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fingers swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Urgency to defecate | Gastrointestinal disorders | Systematic Assessment |
|
| Foot peripheral edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gout in arches of feet | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bladder infection | Infections and infestations | Systematic Assessment |
|
| Increased hunger | General disorders | Systematic Assessment |
|
| Muscle twitching in upper back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Change in appearance of stool | Gastrointestinal disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Vivid dreams | General disorders | Systematic Assessment |
|
| Nerve pain down arms and legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Loss of nails | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 | Digestive System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |