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A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

Primary Purpose

Gastroparesis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CIN-102 Dose 1
CIN-102 Dose 2
CIN-102 Dose 3
Placebo
Sponsored by
CinDome Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients 18 to 70 years old.
  • Current diagnosis of idiopathic or diabetic gastroparesis OR documented delayed gastric emptying.
  • Presence of moderate to severe nausea.
  • Body mass index (BMI) between 18 and 40 kg/m2, inclusive.
  • Glycosylated hemoglobin level <11% at Screening.
  • Willing to washout from ongoing treatment for gastroparesis.
  • Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

  • Other known disorder or treatment which could explain or contribute to symptoms of gastroparesis.
  • Positive test for drugs of abuse at the screening or evaluation visits.
  • Personal or family history of prolonged heart rate-corrected QT.
  • History or evidence of clinically significant arrhythmia.
  • History of gastrectomy, fundoplication, vagotomy, pyloroplasty, or bariatric surgery.
  • Females who are pregnant, nursing, or planning on becoming pregnant during the study.

Sites / Locations

  • Research Site 101
  • Research Site 114
  • Research Site 117
  • Research Site 118
  • Research Site 111
  • Research Site 110
  • Research Site 103
  • Research Site 112
  • Research Site 104
  • Research Site 102
  • Research Site 121
  • Research Site 113
  • Research Site 109
  • Research Site 120
  • Research Site 105
  • Research Site 106
  • Research Site 119
  • Research Site 115
  • Research Site 107

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Active Comparator

Arm Label

Cohort 1

Cohort 1 - Placebo

Cohort 2

Cohort 2- Placebo

Cohort 3

Cohort 3- Placebo

Arm Description

CIN-102 tablets by mouth twice daily for 14 days

Placebo tablets by mouth twice daily for 14 days

CIN-102 tablets by mouth twice daily for 14 days

Placebo tablets by mouth twice daily for 14 days

CIN-102 tablets by mouth twice daily for 14 days

Placebo tablets by mouth twice daily for 14 days

Outcomes

Primary Outcome Measures

Change from baseline in gastric emptying

Secondary Outcome Measures

Change from baseline in gastric emptying terminal phase elimination half life
The change from baseline in ANMS GCSI-DD total scores
The change from baseline in ANMS GCSI-DD subscale scores

Full Information

First Posted
July 17, 2019
Last Updated
July 16, 2021
Sponsor
CinDome Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04026997
Brief Title
A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
December 17, 2020 (Actual)
Study Completion Date
December 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CinDome Pharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, PK, and dose response of oral CIN-102 in adults with idiopathic and diabetic gastroparesis. The study will assess three oral doses of CIN-102 versus placebo in three separate cohorts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
CIN-102 tablets by mouth twice daily for 14 days
Arm Title
Cohort 1 - Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets by mouth twice daily for 14 days
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
CIN-102 tablets by mouth twice daily for 14 days
Arm Title
Cohort 2- Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets by mouth twice daily for 14 days
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
CIN-102 tablets by mouth twice daily for 14 days
Arm Title
Cohort 3- Placebo
Arm Type
Active Comparator
Arm Description
Placebo tablets by mouth twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
CIN-102 Dose 1
Intervention Description
CIN-102 Dose 1
Intervention Type
Drug
Intervention Name(s)
CIN-102 Dose 2
Intervention Description
CIN-102 Dose 2
Intervention Type
Drug
Intervention Name(s)
CIN-102 Dose 3
Intervention Description
CIN-102 Dose 3
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in gastric emptying
Time Frame
Baseline (gathered on Days -10 to -3) to Day 14
Secondary Outcome Measure Information:
Title
Change from baseline in gastric emptying terminal phase elimination half life
Time Frame
Baseline (gathered on Days -10 to -3) to Day 14
Title
The change from baseline in ANMS GCSI-DD total scores
Time Frame
Day -14 to 14
Title
The change from baseline in ANMS GCSI-DD subscale scores
Time Frame
Day -14 to 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients 18 to 70 years old. Current diagnosis of idiopathic or diabetic gastroparesis OR documented delayed gastric emptying. Presence of moderate to severe nausea. Body mass index (BMI) between 18 and 40 kg/m2, inclusive. Glycosylated hemoglobin level <11% at Screening. Willing to washout from ongoing treatment for gastroparesis. Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines. Exclusion Criteria: Other known disorder or treatment which could explain or contribute to symptoms of gastroparesis. Positive test for drugs of abuse at the screening or evaluation visits. Personal or family history of prolonged heart rate-corrected QT. History or evidence of clinically significant arrhythmia. History of gastrectomy, fundoplication, vagotomy, pyloroplasty, or bariatric surgery. Females who are pregnant, nursing, or planning on becoming pregnant during the study.
Facility Information:
Facility Name
Research Site 101
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Research Site 114
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Research Site 117
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Research Site 118
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Research Site 111
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Research Site 110
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66045
Country
United States
Facility Name
Research Site 103
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Research Site 112
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Research Site 104
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Research Site 102
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Research Site 121
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Research Site 113
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Research Site 109
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Research Site 120
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site 105
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Research Site 106
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Research Site 119
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Research Site 115
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Research Site 107
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis

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