Phase 3 Gastroparesis Trial, Terminated NCT03420781 Sponsor: Allergan Condition: Gastroparesis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial looked at a medication called relamorelin (given as a 10 microgram injection) compared to a placebo (an inactive injection) in people with diabetic gastroparesis — a condition where the stomach empties more slowly than normal due to diabetes. A total of 467 participants started the main 40-week treatment phase (236 on placebo, 231 on relamorelin), and a smaller group of 193 participants then went on to a further 6-week follow-up period. The trial tracked participants' daily symptom scores covering nausea, abdominal pain, bloating, and the feeling of fullness after eating, as well as vomiting episodes. The reported data shows that at the start of the trial, both groups had very similar average total symptom scores of around 24.8–24.9 out of a possible 40 (where higher scores mean worse symptoms). After 12 weeks, both groups showed a decrease in their scores — the placebo group's score fell by about 11.9 points on average, and the relamorelin group's score fell by about 11.2 points. For the vomiting measure, 29.4% of the placebo group and 21.4% of the relamorelin group met the criterion of having no vomiting episodes across the last six of those first 12 weeks. The reported data also shows that for the secondary measures — including the proportion of participants who had meaningful improvements in nausea, abdominal pain, bloating, and post-meal fullness — the figures were broadly similar between the two groups, ranging from roughly 36% to 46% depending on the symptom and group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Gastroparesis Trial, Terminated

NCT03420781
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must have taken part in one of two related studies (NCT03285308 or NCT03426345) and completed it successfully, meeting all of that study's requirements.
  • You must be able to read and sign a consent form before any study activities begin, and be willing and able to follow all study procedures.
  • In the opinion of the study doctor, you must have followed the rules and procedures of the previous related study well enough.

Who may not be able to join:

  • You are not willing or able to follow the rules about which other medicines you can or cannot take during the study.
  • You are planning to take part in another study involving an experimental drug or medical device at any point during this trial.
  • You currently have an unresolved side effect or a concerning finding from a physical exam, blood/lab test, or heart tracing (ECG) that the study doctor believes would prevent you from safely completing the study.
  • You have kidney, liver, or heart/lung disease, or any other condition that the study doctor believes could make it unsafe for you to participate or could affect the study results (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Wieslaw Bochenek, Allergan

Australian sites

Nepean Hospital, Kingswood, New South Wales
Royal Adelaide Hospital, Adelaide, South Australia
Royal Melbourne Hospital, Parkville, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
24 January 2018
Est. completion
30 October 2020

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇴 Colombia 🇩🇰 Denmark 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇱 Israel 🇱🇻 Latvia 🇲🇾 Malaysia 🇲🇽 Mexico 🇵🇭 Philippines 🇵🇱 Poland 🇷🇺 Russia 🇸🇬 Singapore 🇿🇦 South Africa 🇰🇷 South Korea 🇹🇭 Thailand 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period; Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov