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Futility found by interim analysis
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Comparative-effectiveness study of the treatment of acute bacterial sinusitis with amoxicillin/clavulanate 875mg/125mg bid for 7 days with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. .
Double-blind comparative-effectiveness study of the treatment of acute bacterial sinusitis with standard dose of amoxicillin/clavulanate 875mg/125mg bid for 7 days, as recommended by the Infectious Disease Society of America, with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. The study aims are 1) to confirm, or not, our recent findings of more rapid improvement in overall symptoms with the additional amoxicillin, but also of more frequent diarrhea and vaginal yeast infections and 2) to assess, from the participants' point of view, the balance between improvement and adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose | Experimental | Amoxicillin/clavulanate 875mg/125mg & amoxicillin 875 mg twice a day x 7 days |
|
| Standard dose | Active Comparator | Amoxicillin/clavulanate 875 mg/125mg & placebo (lactase) twice a day x 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin 875 mg | Drug | Doubling the dose of amoxicillin by adding amoxicillin 875 to each dose of the standard treatment of amoxicillin/clavulanate 875/125 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Global Rating of Improvement of 5 & 6 at the End of 3 Days of Treatment | Rating on a scale of 1=a lot worse, 2=a little worse, 3=the same, 4=a little better, 5=a lot better, 6=no symptoms, with a higher score indicating greater improvement. | At end of 3 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Global Rating of Improvement of 5 or 6 at End of 10 Days Since Enrollment | Rating of 5 (a lot better) or 6 (no symptoms) on Global Rating of Improvement scale, with range of 1 (a lot worse) to 6 (no symptoms), with a higher score indicating greater improvement | At end of 10 days since enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Any Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea | Among those who indicated at enrollment whether prone to diarrhea or not, the number giving ratings of 1, 2, or 3 on diarrhea scale ranging from 0 (none) to 3 (severe) | At the end of 3 days |
| Number of Participants Reporting Severe Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul C Sorum, MD, PhD | Albany Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center Internal Medicine and Pediatrics | Cohoes | New York | 12047 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22438350 | Background | Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, Pankey GA, Seleznick M, Volturo G, Wald ER, File TM Jr; Infectious Diseases Society of America. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clin Infect Dis. 2012 Apr;54(8):e72-e112. doi: 10.1093/cid/cir1043. Epub 2012 Mar 20. | |
| 23076918 |
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De-identified IPD will be made available to other researchers by contacting the corresponding author at sorump@amc.edu.
Immediately and indefinitely
Contact the corresponding author at sorump@amc.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose | Amoxicillin/clavulanate 875mg/125mg & amoxicillin 875 mg twice a day x 7 days Amoxicillin 875 mg: Doubling the dose of amoxicillin by adding amoxicillin 875 to each dose of the standard treatment of amoxicillin/clavulanate 875/125 |
| FG001 | Standard Dose | Amoxicillin/clavulanate 875 mg/125mg & placebo (lactase) twice a day x 7 days. Placebo (lactase): Placebo (in place of additional amoxicillin in experimental arm) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | Amoxicillin 875 mg/clavulanate 125 mg + amoxicillin 875 mg twice a day x 7 days |
| BG001 | Standard Dose | Amoxicillin 875 mg/clavulanate 125 mg + placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With a Global Rating of Improvement of 5 & 6 at the End of 3 Days of Treatment | Rating on a scale of 1=a lot worse, 2=a little worse, 3=the same, 4=a little better, 5=a lot better, 6=no symptoms, with a higher score indicating greater improvement. | Participants who provided a Global Rating of Improvement when contacted at the end of 3 days of treatment. | Posted | Count of Participants | Participants | At end of 3 days of treatment |
|
10 days since enrollment
Participants were asked about adverse events at the end of 3 and 10 days. Since they were are office patients, we would have been aware of deaths or serious adverse events
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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 | High Dose | Amoxicillin 875 mg/clavulanate 125 mg + amoxicillin 875 mg twice a day x 7 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe diarrhea at day 3 | Gastrointestinal disorders | Systematic Assessment | Rating of 3 on a diarrhea scale ranging from 0 (none) to 3 (severe) |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Sorum | Albany Medical College | 518-262-7500 | sorump@amc.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 | Feb 11, 2018 | Oct 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D043322 | Lactase |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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Unlabeled bottles of study medications, identified only by participant #, prepared by the pharmacist member of research team. The placebo will be similar in appearance to plain amoxicillin. The pills inside the bottle will be difficult to see until the bottle is opened by the patient.
|
| Placebo (lactase) | Dietary Supplement | Placebo (in place of additional amoxicillin in experimental arm) |
|
| Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 3 Days of Treatment |
The change between enrollment and the end of 3 days of treatment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms. |
| At end of 3 days of treatment |
| Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 10 Days Since Enrollment | The change between enrollment and the end of 10 days since enrollment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms. | At end of 10 days since enrollment |
| Balance of Benefits and Detriments | Assessment of balance between good effects and bad effects of antibiotic on scale of -3=bad effects much greater than good effects to +3=good effects much greater than bad effects | At end of 10 days since enrollment |
| Number of Participants Answering "Yes" to Willingness to Take the Antibiotic Again in the Future | Response of "yes" at the end of 10 days since enrollment to the question whether the participant would take this antibiotic again, with possible answers of yes, no, or uncertain. | At end of 10 days since enrollment |
Among those reporting proneness to diarrhea or not at enrollment, the number rating 3 on diarrhea scale ranging from 0 (none) to 3 (severe) |
| At end of day 3 |
| Number of Participants Reporting Any Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | Among those indicating at enrollment a proneness or not to diarrhea, the number giving ratings of 1, 2, or 3 on the diarrhea scale ranging from 0 (none) to 3 (severe) | At 10 days since enrollment |
| Number of Participants Reporting Severe Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | Among those indicating proneness to diarrhea or not at enrollment, the number who gave a rating of 3 on the diarrhea scale ranging from 0 (none) to 3 (severe) | At 10 days since enrollment |
| Number of Female Participants Reporting Any Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | Female participants contacted after 3 days of treatment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave ratings of 1, 2, or 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. | After 3 days of treatment |
| Number of Female Participants Reporting Severe Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | Among female participants indicating a proneness or not to vaginal itching or discharge, the number of ratings of 3 on the vaginal symptom scale ranging from 0 (none) to 3 (severe)Female participants contacted after 3 days of treatment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave a rating of 1, 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. | At the end of 3 days of treatment |
| Number of Female Participants Reporting Any Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | Female participants contacted after 10 days since enrollment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave ratings of 1, 2, or 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. | At 10 days since enrollment |
| Number of Female Participants Reporting Severe Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | Female participants contacted at 10 days since enrollment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave rating of 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. | At 10 days since enrollment |
| Lemiengre MB, van Driel ML, Merenstein D, Young J, De Sutter AI. Antibiotics for clinically diagnosed acute rhinosinusitis in adults. Cochrane Database Syst Rev. 2012 Oct 17;10:CD006089. doi: 10.1002/14651858.CD006089.pub4. |
| 9493813 | Background | Canafax DM, Yuan Z, Chonmaitree T, Deka K, Russlie HQ, Giebink GS. Amoxicillin middle ear fluid penetration and pharmacokinetics in children with acute otitis media. Pediatr Infect Dis J. 1998 Feb;17(2):149-56. doi: 10.1097/00006454-199802000-00014. |
| 19564277 | Background | Wald ER, Nash D, Eickhoff J. Effectiveness of amoxicillin/clavulanate potassium in the treatment of acute bacterial sinusitis in children. Pediatrics. 2009 Jul;124(1):9-15. doi: 10.1542/peds.2008-2902. |
| 33755168 | Derived | Gregory J, Huynh B, Tayler B, Korgaonkar-Cherala C, Garrison G, Ata A, Sorum P. High-Dose vs Standard-Dose Amoxicillin Plus Clavulanate for Adults With Acute Sinusitis: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e212713. doi: 10.1001/jamanetworkopen.2021.2713. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Smoking (No. [%] | Count of Participants | Participants |
|
| Asthma or COPD | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Allergic rhinitis | Count of Participants | Participants |
|
| Heart disease | Count of Participants | Participants |
|
| History of sinusitis | Count of Participants | Participants |
|
| Hospitalized in past month | Count of Participants | Participants |
|
| Antibiotics in past month | Count of Participants | Participants |
|
| Using nasal steroids | Count of Participants | Participants |
|
| Enrolled in previous study | Count of Participants | Participants |
|
| Days of illness prior to enrollment | Mean | Standard Deviation | days |
|
| Sinusitis category 1 (duration 10 days or greater) | Count of Participants | Participants |
|
| Sinusitis category 2 (severe symptoms) | Count of Participants | Participants |
|
| Sinusitis category 3 (double sickening) | Count of Participants | Participants |
|
| Sinonasal Outcome Test-16 total score | Sum of the ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. | Mean | Standard Deviation | units on a scale |
|
| Tend to be constipated | Count of Participants | Participants |
|
| Prone to diarrhea | Count of Participants | Participants |
|
| Tend to get vaginal yeast infections | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With a Global Rating of Improvement of 5 or 6 at End of 10 Days Since Enrollment | Rating of 5 (a lot better) or 6 (no symptoms) on Global Rating of Improvement scale, with range of 1 (a lot worse) to 6 (no symptoms), with a higher score indicating greater improvement | Participants who could be reached to give a global rating at the end of 10 days since enrollment. | Posted | Count of Participants | Participants | At end of 10 days since enrollment |
|
|
|
| Secondary | Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 3 Days of Treatment | The change between enrollment and the end of 3 days of treatment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms. | Participants who provided a SNOT-16 rating when reached at the end of 3 days | Posted | Mean | Standard Deviation | score on a scale | At end of 3 days of treatment |
|
|
|
| Secondary | Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 10 Days Since Enrollment | The change between enrollment and the end of 10 days since enrollment in the total score on the Sinonasal Outcome Test-16 (SNOT-16). The total SNOT-16 is the sum of the participant's ratings of 16 symptoms of illness on the scale of 0 (no problem) to 3 (severe problem), with a possible range of 0 to 48, with a higher sum indicating more troubling symptoms. A decrease in total score would indicate an improvement in symptoms. | Participants who could be reached at 10 days since enrollment | Posted | Mean | Standard Deviation | score on a scale | At end of 10 days since enrollment |
|
|
|
| Secondary | Balance of Benefits and Detriments | Assessment of balance between good effects and bad effects of antibiotic on scale of -3=bad effects much greater than good effects to +3=good effects much greater than bad effects | Participants who could be reached to assess their treatment at 10 days since enrollment | Posted | Mean | Standard Deviation | score on a scale | At end of 10 days since enrollment |
|
|
|
| Secondary | Number of Participants Answering "Yes" to Willingness to Take the Antibiotic Again in the Future | Response of "yes" at the end of 10 days since enrollment to the question whether the participant would take this antibiotic again, with possible answers of yes, no, or uncertain. | Participants who could be reached at day 10 to assess their treatment | Posted | Count of Participants | Participants | At end of 10 days since enrollment |
|
|
|
| Other Pre-specified | Number of Participants Reporting Any Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea | Among those who indicated at enrollment whether prone to diarrhea or not, the number giving ratings of 1, 2, or 3 on diarrhea scale ranging from 0 (none) to 3 (severe) | Participants giving a rating of diarrhea at the end of day 3 | Posted | Count of Participants | Participants | At the end of 3 days |
|
|
|
| Other Pre-specified | Number of Participants Reporting Severe Diarrhea at Day 3 Among Those Self-identified as Prone or Not Prone to Diarrhea | Among those reporting proneness to diarrhea or not at enrollment, the number rating 3 on diarrhea scale ranging from 0 (none) to 3 (severe) | Participants who indicated whether prone to diarrhea or not at enrollment and then at follow-up rated their diarrhea | Posted | Count of Participants | Participants | At end of day 3 |
|
|
|
| Other Pre-specified | Number of Participants Reporting Any Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | Among those indicating at enrollment a proneness or not to diarrhea, the number giving ratings of 1, 2, or 3 on the diarrhea scale ranging from 0 (none) to 3 (severe) | Participants indicating their adverse effects at 10 days | Posted | Count of Participants | Participants | At 10 days since enrollment |
|
|
|
| Other Pre-specified | Number of Participants Reporting Severe Diarrhea at Day 10 Among Those Self-identified as Prone or Not Prone to Diarrhea | Among those indicating proneness to diarrhea or not at enrollment, the number who gave a rating of 3 on the diarrhea scale ranging from 0 (none) to 3 (severe) | Participants who gave ratings of adverse effects at day 10 | Posted | Count of Participants | Participants | At 10 days since enrollment |
|
|
|
| Other Pre-specified | Number of Female Participants Reporting Any Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | Female participants contacted after 3 days of treatment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave ratings of 1, 2, or 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. | Female participants available at the end of 3 days of treatment who had indicated proneness or not to vaginal symptoms at enrollment | Posted | Count of Participants | Participants | After 3 days of treatment |
|
|
|
| Other Pre-specified | Number of Female Participants Reporting Severe Vaginal Symptoms at Day 3 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | Among female participants indicating a proneness or not to vaginal itching or discharge, the number of ratings of 3 on the vaginal symptom scale ranging from 0 (none) to 3 (severe)Female participants contacted after 3 days of treatment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave a rating of 1, 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. | Female participants reporting adverse effects at day 3 | Posted | Count of Participants | Participants | At the end of 3 days of treatment |
|
|
|
| Other Pre-specified | Number of Female Participants Reporting Any Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | Female participants contacted after 10 days since enrollment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave ratings of 1, 2, or 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. | Posted | Count of Participants | Participants | At 10 days since enrollment |
|
|
|
| Other Pre-specified | Number of Female Participants Reporting Severe Vaginal Symptoms at Day 10 Among Those Self-identified as Prone or Not Prone to Vaginal Itching or Discharge | Female participants contacted at 10 days since enrollment were divided into two groups: those who had or had not reported at baseline a proneness to vaginal symptoms. The measure was the number in each group who gave rating of 3 on the vaginal symptoms scale, ranging from 0 (none) to 3 (severe), with a higher score indicating more severe symptoms. | Female participants giving ratings of adverse effects at day 10 | Posted | Count of Participants | Participants | At 10 days since enrollment |
|
|
|
| 0 |
| 78 |
| 0 |
| 78 |
| 53 |
| 78 |
| EG001 | Standard Dose | Amoxicillin 875 mg/clavulanate 125 mg + placebo | 0 | 79 | 0 | 79 | 52 | 79 |
|
| Any diarrhea day 3 | Gastrointestinal disorders | Systematic Assessment | Rating of 1, 2, or 3 on a diarrhea scale ranging from 0 (none) to 3 (severe) |
|
| Severe diarrhea day 10 | Gastrointestinal disorders | Systematic Assessment | Rating of 3 on a diarrhea scale ranging from 0 (none) to 3 (severe) |
|
| Any diarrhea day 10 | Gastrointestinal disorders | Systematic Assessment | Score of 1, 2, or 3 on a diarrhea scale ranging from 0 (none) to 3 (severe) |
|
| Severe vaginal itching or discharge day 3 | Infections and infestations | Systematic Assessment | Rating of 3 on vaginal symptom scale ranging from 0 (none) to 3 (severe) |
|
| Any vaginal itching or discharge day 3 | Infections and infestations | Systematic Assessment | Rating of 1, 2, or 3 on vaginal symptom scale ranging from 0 (none) to 3 (severe) |
|
| Severe vaginal discharge or itching day 10 | Infections and infestations | Systematic Assessment | Score of 3 on vaginal symptoms scale ranging from 0 (none) to 3 (severe) |
|
| Any vaginal itching or discharge day 10 | Infections and infestations | Systematic Assessment | Score of 1, 2, or 3 on vaginal symptom scale ranging from 0 (none) to 3 (severe) |
|
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001616 | beta-Galactosidase |
| D005696 | Galactosidases |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |