Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT02463305
Status:
WITHDRAWN
Last Update Posted:
2023-04-06
First Post:
2015-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'inability to enroll', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2015-05-27', 'studyFirstSubmitQcDate': '2015-06-01', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in endoscopic assessment of mucosal inflammation in ulcerative colitis.', 'timeFrame': '8 weeks', 'description': 'As defined by the Mayo endoscopic score for ulcerative colitis.'}], 'secondaryOutcomes': [{'measure': 'Clinical response in ulcerative colitis disease activity.', 'timeFrame': '8 weeks', 'description': 'As defined by the Mayo composite score for ulcerative colitis.'}, {'measure': 'Intestinal permeability', 'timeFrame': '8 weeks', 'description': 'As measured by urinary saccharide excretion'}, {'measure': 'Patient symptom severity', 'timeFrame': '8 weeks', 'description': "As measured by inflammatory bowel disease questionnaire (IBDQ), simple Crohn's and colitis activity index (SCCAI), and Mayo composite scores."}, {'measure': 'Colonic inflammation', 'timeFrame': '8 weeks', 'description': 'As assessed by fecal calprotectin, CRP, and histologic scoring.'}, {'measure': 'Creatine kinase modulation', 'timeFrame': '8 weeks', 'description': 'As assessed by CK transcript and protein in colonic tissue and serum levels.'}, {'measure': 'Clinical remission of ulcerative colitis disease activity.', 'timeFrame': '8 weeks', 'description': 'As defined by the Mayo composite score for ulcerative colitis.'}, {'measure': 'Creatine modulation', 'timeFrame': '8 weeks', 'description': 'As defined by colonic tissue and serum levels.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colitis, ulcerative', 'Inflammatory bowel diseases'], 'conditions': ['Colitis, Ulcerative']}, 'descriptionModule': {'briefSummary': 'This study plans to learn more about the effects that creatine monohydrate has on disease activity in ulcerative colitis. Creatine is a substance that is naturally produced by the body and is found in foods, such as meat and fish. Creatine helps to provide energy to some body tissues, such as the colon. In the colon, this energy allows cells to form a tight barrier between molecules in digested food and bacteria and the body\'s infection-fighting cells within the colon underneath this barrier. If the barrier becomes "leaky" molecules may pass through and lead to inflammation. This "leakiness" may contribute to the colon inflammation seen in ulcerative colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged 18-70 years old with mild- to moderately-active UC that extends at least 15 cm proximal to the anal verge (i.e. not proctitis) as defined by a Mayo Score of 3-10, with an endoscopic subscore ≥ 1.\n* Allowed concomitant medications will include mesalamine compounds if used for at least 8 weeks and at a stable dose for at least 4 weeks, as well as thiopurines (azathioprine, 6-mercaptopurine) if used at a stable dose for at least 3 months.\n\nExclusion Criteria:\n\n* Abnormal baseline laboratory tests:\n\n * Albumin \\< 3.0 g/dL\n * ALT, AST, total bilirubin, or alkaline phosphatase \\> 1.5 x ULN\n * Potassium \\< 3.0 mmol/L or \\> 5.5 mmol/L\n * Creatinine or cystatin C \\> ULN\n * WBC ≤ 3000\n * Platelets ≤ 105\n * Hemoglobin ≤ 10g/dL\n * Positive stool test for Clostridium difficile, ova and parasites, or routine stool culture\n* Pregnancy (as confirmed by urine pregnancy test at study outset), stated desire to become pregnant during the study period, or refusal/inability to use effective methods of contraception during the study period.\n* Concomitant major comorbidities (renal, hepatic, cardiac, pulmonary or malignancy) to include any medical conditions requiring therapeutic anti-coagulation or anti-platelet therapy.\n* Diagnosis of severe UC (Mayo Score \\> 10)\n* Evidence or history of toxic megacolon\n* Patients who received anti-TNF agents within 3 months of screening, or who used oral or rectal corticosteroids within 4 weeks of screening will be excluded.\n* Use of over-the-counter herbal or dietary supplements (excluding vitamin and minerals) two weeks prior to or during the study period.\n* Use of known nephrotoxic medications (including non-steroidal anti-inflammatory drugs (NSAIDs), cyclosporin A, tacrolimus, aminoglycoside antibiotics, diuretics, angiotensin converting enzyme (ACE) inhibitors, or angiotensin receptor blockers) 2 weeks prior to or during the study period\n* Prior surgical bowel resections (excluding appendectomy)\n* Local or systemic complications or other pathological states requiring therapy with corticosteroids and/or immunosuppressive agents.'}, 'identificationModule': {'nctId': 'NCT02463305', 'briefTitle': 'Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)', 'orgStudyIdInfo': {'id': '13-3054'}, 'secondaryIdInfos': [{'id': 'UL1TR001082', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001082', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': '6 patients with mild-moderate ulcerative colitis treated with creatine monohydrate 21 grams per day in three divided doses taken with water for 8 weeks.', 'interventionNames': ['Drug: Creatine monohydrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': '6 patients with mild-moderate ulcerative colitis treated with placebo (matching creatine monohydrate) 21 grams per day in three divided doses taken with water for 8 weeks.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Optional Open-Label Treatment arm', 'description': 'Up to 6 patients, who were randomized to the placebo arm, will be given the option to continue with open-label creatine monohydrate treatment at 21 grams per day in three divided doses, taken with water, for 8 weeks. Only non-invasive testing will be performed.', 'interventionNames': ['Drug: Creatine monohydrate']}], 'interventions': [{'name': 'Creatine monohydrate', 'type': 'DRUG', 'description': '21 grams creatine monohydrate total per day', 'armGroupLabels': ['Optional Open-Label Treatment arm', 'Treatment arm']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Dextrose'], 'description': '7 grams of dextrose dissolved in 500mL water, taken three times daily', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Mark Gerich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado Denver, Division of Gastroenterology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}