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NCT02210000 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
114
Enrollment target

NCT02210000: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT02210000 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02210000, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
114 participants
Enrollment target

Study Summary

This study is a randomized, double-blind, placebo controlled trial designed to confirm the symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1 and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine if a low-dose of camicinal (25 milligram\[mg\]) for 12 weeks of repeat administration improves gastroparesis symptoms as measured by the Gastrointestinal Cardinal Symptom Index - Daily Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2 diabetes mellitus (DM) who have documented abnormally slow gastric emptying and have symptoms consistent with gastroparesis. Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a 2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety follow-up visit.

Primary Outcome

The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an impr

Interventions

  • DRUG Placebo
  • DRUG Camicinal

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2014-08-27
Est. Completion 2015-08-24
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT02210000 record still lists

NCT02210000 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02210000 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02210000 about?

NCT02210000 is a clinical study titled "A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis". This study is a randomized, double-blind, placebo controlled trial designed to confirm the symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1 and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine if a low-dose of camici...

What is the current status of trial NCT02210000?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2014-08-27. Estimated completion is 2015-08-24.

What interventions are being tested in trial NCT02210000?

The interventions under investigation include: Placebo (DRUG), Camicinal (DRUG).

Who is sponsoring clinical trial NCT02210000?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02210000's enrollment target sits among peer trials

114 627th of 2000 higher than 1,370 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02210000, the US trial registry maintained by the National Library of Medicine. NCT02210000 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.