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Anal fissure is a solitary ulcer in the squamous epithelium of the anus causing intense anal pain especially during defecation and for 1 or 2 hours afterwards. There are no approved drugs in the United States (US) for this condition and surgery is often the treatment choice. Strakan is conducting this confirmatory study so the product can be submitted for regulatory approval in the US. Strakan currently markets this product throughout Europe.
The objective of this study is to determine the effect of nitroglycerin ointment 0.4% (Cellegesic) versus placebo on average pain intensity over every 24 hour period for up to 21 days of treatment in 250 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellegesic (nitroglycerin 0.4%) | Experimental | Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. |
|
| Placebo 375 mg | Placebo Comparator | Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellegesic | Drug | Cellegesic was supplied as an ointment containing 0.4% w/w nitroglycerin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Intensity at Days 14-18 | Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated and used to determine the change from Baseline. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement. | Baseline to Day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to an Improvement in Pain Intensity | Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale (VAS) at Baseline and on each of the 21 treatment days of the study. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. Improvement was defined as either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in rated pain intensity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gemma Clark | Strakan Pharmaceuticals, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23815124 | Derived | Berry SM, Barish CF, Bhandari R, Clark G, Collins GV, Howell J, Pappas JE, Riff DS, Safdi M, Yellowlees A. Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study. BMC Gastroenterol. 2013 Jul 1;13:106. doi: 10.1186/1471-230X-13-106. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cellegesic (Nitroglycerin 0.4%) | Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. |
| FG001 | Placebo | Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: All participants who received at least 1 application of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cellegesic (Nitroglycerin 0.4%) | Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. |
| BG001 | Placebo |
| 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 | Change From Baseline in Pain Intensity at Days 14-18 | Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated and used to determine the change from Baseline. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. A negative change score indicated improvement. | Intent-to-treat population: All randomized participants who had applied the study medication at least once. | Posted | Mean | Standard Error | Units on a scale | Baseline to Day 18 |
|
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Safety population: All participants who received at least 1 application of study medication.
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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 | Cellegesic (Nitroglycerin 0.4%) | Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Fox, PhD | Allergan plc | 201-427-8225 | susan.fox@allergan.com |
| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo was supplied as an ointment identical to Cellegesic ointment except that it contained no nitroglycerin. |
|
| Baseline to Day 21 |
| Percentage of Responders | Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. A responder was defined as a participant with either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in the 24 hour average pain intensity averaged over Days 14 to 18. | Baseline to Day 18 |
| Lost to Follow-up |
|
| Voluntary withdrawal |
|
| Did not receive treatment |
|
Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo | Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. |
|
|
| Secondary | Time to an Improvement in Pain Intensity | Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale (VAS) at Baseline and on each of the 21 treatment days of the study. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. Improvement was defined as either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in rated pain intensity. | Intent-to-treat population: All randomized participants who had applied the study medication at least once. Only participants with an improvement in pain intensity were included in the analysis. | Posted | Mean | Standard Error | Days | Baseline to Day 21 |
|
|
|
| Secondary | Percentage of Responders | Participants rated the pain associated with their chronic anal fissure over the preceding 24 hours on a 100 mm visual analog scale at Baseline and on Days 14 through 18. The average pain rating on Days 14 through 18 was calculated. The left-end of the visual analog scale was labelled "least possible pain" and the right-end of the visual analog scale was labelled "worst possible pain". The pain rating ranged from 0 to 100, with a higher score indicating more pain. A responder was defined as a participant with either a ≥ 50% decrease or a ≥ 10 mm decrease from Baseline in the 24 hour average pain intensity averaged over Days 14 to 18. | Intent-to-treat population: All randomized participants who had applied the study medication at least once. | Posted | Number | Percentage of responders | Baseline to Day 18 |
|
|
|
| 2 |
| 123 |
| 96 |
| 123 |
| EG001 | Placebo | Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days. | 1 | 124 | 67 | 124 |
| Osteomyelitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Anal sphincterotomy | Surgical and medical procedures | MedDRA (10.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
Publication statement in clinical trial agreement.
| D004066 |
| Digestive System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |