Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT02015260
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003218', 'term': 'Condylomata Acuminata'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Investigator assessment of staining', 'timeFrame': '12 weeks', 'description': 'Investigator assessment of staining (present or absent) at treatment site at Weeks 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion'}], 'primaryOutcomes': [{'measure': 'Proportion of patients with complete clearance of target warts in Intention to treat (ITT) population', 'timeFrame': '24 weeks', 'description': '* Number of and area of target warts (up to 10 selected) at Baseline and Week 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion and at follow-up (Weeks 4, 8 and 12 after end of treatment)\n* Number of warts at Baseline (Week 0) and of remaining baseline warts at Week 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion and at Weeks 4, 8 and 12 of follow-up'}], 'secondaryOutcomes': [{'measure': 'Total number of warts (baseline and new) at end of treatment', 'timeFrame': '12 weeks'}, {'measure': 'Patient assessment of efficacy', 'timeFrame': '12 weeks', 'description': 'Patient assessment of efficacy (categorised as complete clearance, significant improvement, partial improvement, no change or worsening) at Week 12/withdrawal/early completion'}, {'measure': 'Investigator assessment of efficacy', 'timeFrame': '12 weeks', 'description': 'Investigator assessment of efficacy (categorised as complete clearance, significant improvement, partial improvement, no change or worsening) at Week 12/withdrawal/early completion'}, {'measure': 'Patient assessment of tolerability', 'timeFrame': '12', 'description': 'Patient assessment of itching, pain and burning (categorised as none, mild, moderate or severe) at treatment site at Screening and Weeks 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion'}, {'measure': 'Investigator assessment of tolerability', 'timeFrame': '12 weeks', 'description': 'Investigator assessment of erythema/eschar and oedema (using modified Draize scales from 0 to 4) at Baseline (Week 0), Weeks 1, 2, 4, 6, 8, 10 and 12/withdrawal/early completion and at follow-up (Weeks 4, 8 and 12 after end of treatment)'}, {'measure': 'Safety of treatment', 'timeFrame': '12 weeks and followed up', 'description': 'Adverse events throughout treatment period; unresolved events at end of treatment were followed up Heart rate and blood pressure at each visit during treatment Laboratory tests at Screening and Week 12/withdrawal/early completion Physical examination at Screening and at Week 12/withdrawal/early completion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['human papilloma virus infection', 'Anogenital warts', 'condylomata acuminata'], 'conditions': ['Anogenital Warts', 'Condylomata Acuminata']}, 'referencesModule': {'references': [{'pmid': '25922903', 'type': 'DERIVED', 'citation': 'Ormerod AD, van Voorst Vader PC, Majewski S, Vanscheidt W, Benjamin N, van der Meijden W. Evaluation of the Efficacy, Safety, and Tolerability of 3 Dose Regimens of Topical Sodium Nitrite With Citric Acid in Patients With Anogenital Warts: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):854-61. doi: 10.1001/jamadermatol.2015.0381.'}]}, 'descriptionModule': {'briefSummary': 'Objective To assess the efficacy of the topical application of Nitric Oxide, delivered using acidified nitrite.\n\nDesign Multicentre, randomized, controlled, dose ranging trial. A control arm and three doses of acidified nitrite applied topically for 12 weeks with a further 12 weeks of follow up.\n\nSetting The trial setting was in European genitourinary medicine clinics\n\nParticipants Male and female volunteers over 18 years of age with between 2 and 50 ano-genital warts, 328 were screened for eligibility and 299 subjects from 40 centres were randomised.\n\nExclusions Pregnancy; concomitant Sexually Transmitted Disease; internal warts requiring treatment other than surgery /laser; diabetes ; Human Immunodeficiency Virus-positive, immunosuppressed and/or using immunosuppressive therapies; drug abuse.\n\ninterventions compared\n\n* Control Placebo nitrite cream and placebo citric acid cream twice daily\n* A) 3% sodium nitrite + 4.5% citric acid creams twice daily\n* B) 6% sodium nitrite + 9% citric acid creams once daily\n* C) 6% sodium nitrite + 9% citric acid creams twice daily\n\nOutcomes\n\n* Primary proportion of patients with complete clearance of target warts Secondary\n* Time to clearance\n* Wart area\n* Wart count\n* Patient and investigator assessment of efficacy\n* Safety\n* Tolerability\n* Adherence'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females over 18 years of age\n* 2-50 warts in the anogenital region.\n* Female patients of child-bearing potential had to be willing to use a non-barrier method of contraception at entry and for the duration of the study.\n* all patients had to be willing to use barrier protection for the duration of the study.\n* All patients had to be able to comply with the requirements of the protocol and be likely to return for follow-up visits and had to be contactable for the duration of the study.\n\nExclusion Criteria:\n\n* Patients with clinically relevant abnormal haematology or biochemistry results (determined from the sample taken at Visit 1).\n* Patients who had used an active therapy for anogenital warts within 2 weeks of randomisation to study drug, i.e. Visit 2.\n* Patients who had used any local supportive medication, including topical corticosteroids or beta-interferon, within 2 weeks of study entry.\n* Patients who had used medication known to adversely affect their haematology profile, including local anaesthetics (benzocaine, lidocaine, etc), nitrofurantoin, sulphonylureas and sulphonamides within 2 weeks of study entry. \\[Word 'adversely' added by Protocol Amendment 2, 7 May 2002.\\]\n* Patients with abnormal anogenital skin, such as eczema, or skin that had not healed following surgery (cryosurgery, laser ablation or similar).\n* Patients who were known to have a concomitant sexually transmitted disease that inhibited accurate assessment of their warts.\n* Patients who required treatment other than surgery or laser for internal warts.\n* Male patients with intra-urethral warts \\[deleted by Protocol Amendment 2, 7 May 2002\\].\n* Patients with diabetes (Type I or Type II diabetes).\n* Patients who were known to be HIV-positive.\n* Patients who were known to be immunosuppressed and/or using immunosuppressive therapies.\n* Patients known to abuse alcohol and/or drugs or with a history of chronic alcohol or drug abuse."}, 'identificationModule': {'nctId': 'NCT02015260', 'briefTitle': 'A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'A Randomised, Multicentre, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate the Efficacy, Safety and Tolerability of Three Dose Regimens of Topical Nitric Oxide in Patients With Anogenital Warts', 'orgStudyIdInfo': {'id': 'ANA/2/C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo 0% nitrite cream and placebo 0% citric acid cream', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical NO Dose A', 'description': '3% sodium nitrite + 4.5% citric acid twice daily', 'interventionNames': ['Drug: Topical NO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical NO Dose B', 'description': '6% sodium nitrite + 9% citric acid once daily', 'interventionNames': ['Drug: Topical NO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical NO Dose C', 'description': '6% sodium nitrite + 9% citric acid twice daily', 'interventionNames': ['Drug: Topical NO']}], 'interventions': [{'name': 'Topical NO', 'type': 'DRUG', 'otherNames': ['Acidified Nitrite vs Placebo'], 'description': 'Varying doses of sodium nitrite and citric acid co-applied to warts', 'armGroupLabels': ['Topical NO Dose A', 'Topical NO Dose B', 'Topical NO Dose C']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo nitrite cream and placebo citric acid cream'], 'description': 'Placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Willem I Van der Meijden', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}