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

Sponsor
CinDome Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04026997
Collaborator
(none)
73
Enrollment
19
Locations
6
Arms
15.2
Actual Duration (Months)
3.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CIN-102 Dose 1
  • Drug: CIN-102 Dose 2
  • Drug: CIN-102 Dose 3
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
73 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 11, 2019
Actual Primary Completion Date :
Dec 17, 2020
Actual Study Completion Date :
Dec 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

CIN-102 tablets by mouth twice daily for 14 days

Drug: CIN-102 Dose 1
CIN-102 Dose 1
Placebo Comparator: Cohort 1 - Placebo

Placebo tablets by mouth twice daily for 14 days

Drug: Placebo
Placebo
Experimental: Cohort 2

CIN-102 tablets by mouth twice daily for 14 days

Drug: CIN-102 Dose 2
CIN-102 Dose 2
Placebo Comparator: Cohort 2- Placebo

Placebo tablets by mouth twice daily for 14 days

Drug: Placebo
Placebo
Experimental: Cohort 3

CIN-102 tablets by mouth twice daily for 14 days

Drug: CIN-102 Dose 3
CIN-102 Dose 3
Active Comparator: Cohort 3- Placebo

Placebo tablets by mouth twice daily for 14 days

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in gastric emptying [Baseline (gathered on Days -10 to -3) to Day 14]

Secondary Outcome Measures

  1. Change from baseline in gastric emptying terminal phase elimination half life [Baseline (gathered on Days -10 to -3) to Day 14]

  2. The change from baseline in ANMS GCSI-DD total scores [Day -14 to 14]

  3. The change from baseline in ANMS GCSI-DD subscale scores [Day -14 to 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site 101 Chula Vista California United States 91910
2 Research Site 114 Jacksonville Florida United States 32224
3 Research Site 117 Miami Florida United States 33134
4 Research Site 118 Miami Florida United States 33183
5 Research Site 111 Atlanta Georgia United States 30322
6 Research Site 110 Kansas City Kansas United States 66045
7 Research Site 103 Louisville Kentucky United States 40202
8 Research Site 112 Marrero Louisiana United States 70072
9 Research Site 104 Monroe Louisiana United States 71201
10 Research Site 102 Boston Massachusetts United States 02215
11 Research Site 121 Omaha Nebraska United States 68134
12 Research Site 113 Las Vegas Nevada United States 89123
13 Research Site 109 Great Neck New York United States 11023
14 Research Site 120 Winston-Salem North Carolina United States 27103
15 Research Site 105 Tulsa Oklahoma United States 74104
16 Research Site 106 Philadelphia Pennsylvania United States 19140
17 Research Site 119 Summerville South Carolina United States 29485
18 Research Site 115 Rapid City South Dakota United States 57702
19 Research Site 107 Jackson Tennessee United States 38305

Sponsors and Collaborators

  • CinDome Pharma, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CinDome Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT04026997
Other Study ID Numbers:
  • CIN-102-121
First Posted:
Jul 19, 2019
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastroparesis

Study Results

No Results Posted as of Jul 21, 2021