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| ID | Type | Description | Link |
|---|---|---|---|
| MEBENDAZOLGAI3003 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.
This will be a double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), multi-center, parallel-group study (each group of participants will be treated at the same time) to evaluate the efficacy and safety of mebendazole (a drug currently being investigated for Helminth gastrointestinal infections) compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in children (including pre-school and school-aged children) with Helminth infections. The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and a post-treatment (or follow-up) phase. A pharmacokinetic (explores what a drug does to the body) open-label substudy (asks a separate research question from the parent study while using the same participant population but does not contribute to the parent study's objectives) will be included in the parent study to measure the level of mebendazole in the blood. Safety assessments will be performed throughout the study. Each participant will take part in the study for approximately 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mebendazole | Active Comparator | Mebendazole will be administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) and in an open-label manner at Visit 4 (Day 21). |
|
| Placebo | Placebo Comparator | Matching placebo will be administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mebendazole | Drug | Mebendazole will be administered as a single-dose 500 mg chewable tablet. For children 1 year to <36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child. |
| Measure | Description | Time Frame |
|---|---|---|
| Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period | Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline. | At Visit 3 (Day 19) of Double-blind treatment period |
| Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period | Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline. | At Visit 3 (Day 19) of Double-blind treatment period |
| Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to Visit 3 (Day 19 +/-2) |
| Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period | Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group. | Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gonder | Ethiopia | |||||
Of the 792 participants screened, a total of 295 were randomly assigned to study treatments, of which 278 completed the study. 17 participants were withdrawn from study with following reasons: Withdrawal by participant (12), Lost to follow-up (3), Physician decision (1) and Protocol violation (1).
The study was conducted from 8-Dec-2014 to 3-Sep-2015. A total of 295 participants were enrolled and randomly assigned to study treatment; 278 participants completed the study. Of the 295 participants, 167 participants were reported with Ascaris lumbricoides infestation and 243 participants were reported with Trichuris trichiura infestation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind Placebo | Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2). |
| FG001 | Double-blind Mebendazole 500 mg | Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2). |
| FG002 | Open-label Mebendazole 500 mg | Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind |
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| Open-label |
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind Placebo | Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2). |
| BG001 | Double-blind Mebendazole 500 mg |
| 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 |
| 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 | Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period | Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline. | The intent-to-treat (ITT) analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At Visit 3 (Day 19) of Double-blind treatment period |
|
Up to visit 5 (Day 26, 7+/-1 days after Visit 3 [Day 19+/-2])
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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 | Double-blind Placebo | Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Night Blindness | Eye disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DIRECTOR CLINICAL LEAD | Janssen R&D US | ClinicalTrialDisclosure@its.jnj.com |
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| ID | Term |
|---|---|
| D014201 | Trematode Infections |
| ID | Term |
|---|---|
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008463 | Mebendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Matching placebo will be administered as a single-dose chewable tablet. For children 1 year to <36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child. |
|
| Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period | Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group. | Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period |
| Maximum Plasma Concentration (Cmax) of Mebendazole | The Cmax is the maximum plasma concentration. | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) |
| Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole | The Time to Reach Maximum Plasma Concentration (Tmax) is time to reach the maximum plasma concentration. | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) |
| Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole | The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose. | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole | The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) |
| Jimma |
| Ethiopia |
| Kigali | Rwanda |
| Protocol Violation |
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| Withdrawal by Subject |
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| NOT COMPLETED |
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Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Double-blind Mebendazole 500 mg |
Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2). |
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|
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| Primary | Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period | Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline. | The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | At Visit 3 (Day 19) of Double-blind treatment period |
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| Primary | Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The safety analysis set consisted of all randomized participants who received 1 dose of study agent (mebendazole or placebo) at baseline. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Number | participants | Up to Visit 3 (Day 19 +/-2) |
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| Secondary | Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period | Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group. | The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Number | percent change in egg count | Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period |
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|
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| Secondary | Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period | Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group. | The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Number | percent change in egg count | Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period |
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| Secondary | Maximum Plasma Concentration (Cmax) of Mebendazole | The Cmax is the maximum plasma concentration. | Pharmacokinetic (PK) population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Mean | Standard Deviation | nanogram per Milliliters (ng/mL) | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) |
|
|
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| Primary | Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The open-label follow-up safety analysis set consisted of all randomized participants who received a 500-mg chewable tablet of mebendazole at Visit 3. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Number | participants | At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3) |
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| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole | The Time to Reach Maximum Plasma Concentration (Tmax) is time to reach the maximum plasma concentration. | PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Mean | Full Range | hours | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) |
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|
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| Secondary | Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole | The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose. | PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Mean | Standard Deviation | nanogram hour per Milliliters(ng*h/mL) | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole | The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. | PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure. | Posted | Mean | Standard Deviation | ng*h/mL | Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3) |
|
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|
| 0 |
| 140 |
| 8 |
| 140 |
| EG001 | Double-blind Mebendazole 500 mg | Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2). | 0 | 144 | 9 | 144 |
| EG002 | OL Mebendazole 500 mg | Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3). | 0 | 278 | 7 | 278 |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Conjunctivitis Bacterial | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Malaria | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Tinea Infection | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA Version 18.0 | Non-systematic Assessment |
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| Soft Tissue Injury | Injury, poisoning and procedural complications | MedDRA Version 18.0 | Non-systematic Assessment |
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| Vitamin A Deficiency | Metabolism and nutrition disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 18.0 | Non-systematic Assessment |
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If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |