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A Study to Evaluate the Safety and Efficacy of NG101 in Adult Participants With Symptomatic Diabetic or Idiopathic Gastroparesis

Sponsor
Neurogastrx, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04303195
Collaborator
(none)
280
Enrollment
103
Locations
4
Arms
32
Anticipated Duration (Months)
2.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of various dose levels of NG101 compared with placebo in adult participants with gastroparesis during 12 weeks of treatment.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a randomized, double-blind, parallel-group , placebo-controlled, multicenter US-based study to evaluate the safety and efficacy of 3 dose levels of NG101 (Metopimazine) compared with placebo in participants with diabetic or idiopathic gastroparesis.

The study will enroll approximately 280 participants. Following the Screening Period, there is a 2-week Pretreatment Period during which participants will complete an electronic daily diary. Participants eligible for the clinical study will be randomly assigned (in a 1:1:1:1 ratio) to receive either NG101 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period. All participants will be asked to take one capsule 30 minutes before a meal 3 times a day and 30 minutes before bedtime for a total of 4 capsules daily (QID). The total duration of the study for each participant will be approximately 20 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study, of the Safety and Efficacy of NG101 Administered Orally to Patients With Gastroparesis
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: NG101 - 5 mg

NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks

Drug: NG101
Capsules
Other Names:
  • metopimazine

    		•
    Experimental: NG101 - 10 mg

    NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks

    Drug: NG101
    Capsules
    Other Names:
  • metopimazine

    		•
    Experimental: NG101 - 20 mg

    NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks

    Drug: NG101
    Capsules
    Other Names:
  • metopimazine

    		•
    Placebo Comparator: Placebo

    Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks

    Drug: NG101
    Capsules
    Other Names:
  • metopimazine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of Severity of Nausea [Baseline to Week 12]

      Change from Baseline at weeks 7 through12 as measured by patient's daily diary entries during participation in the study.

    2. Incidence and severity of Adverse Events [Baseline to Week 12]

      Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)

    Secondary Outcome Measures

    1. Change from Baseline of Symptoms [Baseline to Week 12]

      Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for number of discrete episodes of vomiting.

    2. Change from Baseline of Symptoms [Baseline to Week 12]

      Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for early satiety severity score.

    3. Change from Baseline [Baseline to Week 12]

      Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score.

    4. Change from Baseline [Baseline to Week 12]

      Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for abdominal pain severity score.

    5. Change from Baseline [Baseline to Week 12]

      Change from baseline at Weeks 7 through 12 as measured by patient's daily diary entries during participation in the study for total severity score (nausea, early satiety, postprandial fullness, abdominal pain).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult patients with diabetic or idiopathic gastroparesis

    • Symptoms consistent with gastroparesis (nausea, vomiting, early satiety, post-prandial fullness, and abdominal pain)

    • Documented evidence of no mechanical obstruction

    • Delayed gastric emptying as demonstrated by gastric scintigraphy or breath test

    Exclusion Criteria:

    • Uncontrolled diabetes (defined as HgbA1c > 10%)

    • Severe postural symptoms or evidence of unexplained recurrent dizziness

    • Participant has received and tolerated domperidone and showed no notable symptomatic improvement in gastroparesis symptoms

    • Participant has had endoscopic pyloric injections of botulinum toxin within the 6 months prior to the Screening Visit.

    • Participant engages in daily recreational use of marijuana

    • Prolactin levels > 2 x ULN

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Synexus Clinical Research Birmingham Alabama United States 35211
    2 Digestive Health Specialists Dothan Alabama United States 36305
    3 G & L Research, LLC Foley Alabama United States 36535
    4 East View Medical Research Mobile Alabama United States 36606
    5 Synexus Clinical Resaerch Chandler Arizona United States 85224
    6 Phoenix Medical Group Peoria Arizona United States 85381
    7 Phoenix Clinical LLC Phoenix Arizona United States 85014-2151
    8 Del Sol Research Management Tucson Arizona United States 85715
    9 Preferred Research Partners Little Rock Arkansas United States 72211
    10 GW Research, Inc Chula Vista California United States 91910
    11 Precision Research Institute, LLC Chula Vista California United States 91910
    12 John Muir Physician Network Clinical Research Center Concord California United States 94520
    13 Kindred Medical Institute for Clinical Trials, LLC Corona California United States 92879
    14 Diagnamics Inc. Encinitas California United States 92024
    15 Paragon Rx Clinical, Inc Garden Grove California United States 92840
    16 United Clinical Research Irvine California United States 92618
    17 Prime Care Clinical Rsearch Laguna Hills California United States 92653
    18 Torrance Clinical Research Institute, Inc. Lomita California United States 90717
    19 Angel City Research Los Angeles California United States 90010
    20 United Clinical Research Murrieta California United States 92563
    21 Diabetes Medical Center of California Northridge California United States 91325
    22 Precision Research Institute San Diego California United States 92114
    23 Triwest Research Associates LLC San Diego California United States 92120
    24 Synexus Clinical Research Santa Rosa California United States 95405
    25 Peak Gastroenterology Associates Colorado Springs Colorado United States 80920
    26 Innovative Research of West Florida Clearwater Florida United States 33756
    27 Innovation Medical Group, LLC. Fort Lauderdale Florida United States 33316
    28 Mayo Clinic Jacksonville Jacksonville Florida United States 32224
    29 ENCORE Borland-Grover Clinical Research Jacksonville Florida United States 32256
    30 ClinCloud, LLC Maitland Florida United States 32751
    31 Verus Clinical Research, Corp Miami Florida United States 33125
    32 APF Research, LLC Miami Florida United States 33134
    33 Panax Clinical Research Miami Florida United States 33155-1691
    34 Baptist Diabetes Associates Miami Florida United States 33156
    35 International Research Associates LLC Miami Florida United States 33156
    36 PharmaSouth Research Miami Florida United States 33175
    37 Sensible Healthcare Ocoee Florida United States 34761
    38 Innovation Medical Research Center Palmetto Bay Florida United States 33157
    39 AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg Pinellas Park Florida United States 33781
    40 Advanced Medical Research Center Port Orange Florida United States 32127
    41 Avita Clinical Research Tampa Florida United States 33613
    42 Agile Clinical Research Trials, LLC Atlanta Georgia United States 30328
    43 Gastrointestinal Diseases, Inc. Research Columbus Georgia United States 31904
    44 IResearch Atlanta LLC Decatur Georgia United States 30030
    45 Gastroenterology Associates of Gainesville Gainesville Georgia United States 30501
    46 Synexus Clinical Research Chicago Illinois United States 60602
    47 Claude Mandel Medical Center Chicago Illinois United States 60617
    48 Medisphere Medical Research Center LLC Evansville Indiana United States 47714
    49 Indiana University Hospital Indianapolis Indiana United States 46202
    50 Integrated Clinical Trial Services, Inc. West Des Moines Iowa United States 50265
    51 West Glen GI Shawnee Mission Kansas United States 66217
    52 Kansas Medical Clinic Topeka Kansas United States 66606
    53 University of Louisville Louisville Kentucky United States 40202
    54 Tandem Clinical Research GI, LLC Marrero Louisiana United States 70072
    55 Clinical Trials of America West Monroe Louisiana United States 71291
    56 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21224
    57 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    58 Henry Ford Health System Detroit Michigan United States 48202
    59 Aa Mrc Llc Flint Michigan United States 48504
    60 West Michigan Clinical Research Center Wyoming Michigan United States 49519
    61 AES - DRS - Synexus Clinical Research US, Inc. - St. Louis Saint Louis Missouri United States 63141-7083
    62 KLEO Health & Research Missoula Montana United States 59803
    63 Quality Research Omaha Nebraska United States 68114
    64 Clinical Research of South Nevada Las Vegas Nevada United States 89121
    65 Advanced Biomedical Research of America Las Vegas Nevada United States 89123
    66 Digestive Disease Specialists Las Vegas Nevada United States 89128
    67 Lovelace Respiratory Rsearch Institute Albuquerque New Mexico United States 87108
    68 Synexus Clinical Research New York New York United States 10017
    69 Tandem Clinical Research GI, LLC New York New York United States 10033
    70 Javara Research Charlotte North Carolina United States 28210
    71 Cumberland Research Associates Fayetteville North Carolina United States 28304
    72 Triad Clinical Trials Greensboro North Carolina United States 27410
    73 Carolina Digestive Diseases Greenville North Carolina United States 27834
    74 Synexus Clinical Research Akron Ohio United States 44311
    75 Dayton Gastroenterology Inc. Beavercreek Ohio United States 45440
    76 Hometown Urgent Care and Research Cincinnati Ohio United States 45215
    77 Hometown Urgent Care and Research Columbus Ohio United States 43214
    78 Hometown Urgent Care and Research Dayton Ohio United States 45424
    79 Draelos Metabolic Center Edmond Oklahoma United States 73034
    80 Options Health Research Tulsa Oklahoma United States 74104
    81 AES - DRS - Synexus Clinical Research US, Inc. - Anderson Anderson South Carolina United States 29621
    82 Synexus Clinical Research Greer South Carolina United States 29650
    83 Transsouth Healthcare PC Jackson Tennessee United States 38305
    84 Quality Medical Research Nashville Tennessee United States 37211
    85 Avant Research Associates Austin Texas United States 78704
    86 Texas Tech University Health Sciences Center El Paso Texas United States 79905
    87 Biopharma Informatic, LLC Houston Texas United States 77043
    88 Biopharma Informatic, LLC Houston Texas United States 77084
    89 Sante Clinical Research Kerville Texas United States 78028
    90 Rio Grande Gastroenterology McAllen Texas United States 78503
    91 DM Clinical Research Solutions PC Pearland Texas United States 77584
    92 AES - DRS - Synexus Clinical Research US, Inc. - Plano Plano Texas United States 75093-8157
    93 Sun Research San Antonio Texas United States 78215
    94 Southern Star Research Institute San Antonio Texas United States 78229
    95 Synexus Clinical Research San Antonio Texas United States 78229
    96 Horizon Clinical Research- Tomball Tomball Texas United States 77375
    97 HP Clinical Research Bountiful Utah United States 84010
    98 Synexus Clinical Research Murray Utah United States 84123
    99 Velocity Clinical Research West Jordan Utah United States 84088
    100 Blue Ridge Medical Research Lynchburg Virginia United States 24502
    101 Manassas Clinical Research Center Manassas Virginia United States 20110
    102 Digestive and Liver Disease Specialists Norfolk Virginia United States 23502
    103 Velocity Clinical Research Spokane Spokane Washington United States 99202

    Sponsors and Collaborators

    • Neurogastrx, Inc.

    Investigators

    • Study Director: Stephen Wax, MD, Neurogastrx, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Neurogastrx, Inc.
    ClinicalTrials.gov Identifier:
    NCT04303195
    Other Study ID Numbers:
    • NG101-201
    First Posted:
    Mar 10, 2020
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastroparesis
    Metopimazine

    Study Results

    No Results Posted as of Aug 25, 2022