TerminatedPhase 2

Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia

Stopped: The study was prematurely terminated due to enrollment challenges.

United States9 participantsStarted 2017-04-06

Plain-language summary

The objectives of this study are as follows: In participants with primary Type I or II achalasia, following a single 5-mg dose of olinciguat (IW-1701), * To assess the safety and tolerability * To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM) * To determine the pharmacokinetic (PK) parameters

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Patient has a diagnosis of primary Type I or II achalasia. * Patient has no contraindications to the performance of the baseline and postdose HRIM procedures per Investigator discretion. Key Exclusion Criteria: * Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment with sclerosing agent. * More than 1 pneumatic dilation procedure to a diameter of \> 2 cm in their lifetime. * Pneumatic dilation procedure to a diameter of \> 2 cm within 1 year prior to randomization. Prior bougie dilation(s) or pneumatic dilation(s) ≤ 2 cm are allowed. * Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to randomization or more than 2 esophageal Botox injection procedures in their lifetime. * Patients with malignant or premalignant esophageal lesions. * Patient has taken any drug that can affect gastrointestinal (GI) motility in the 72 hours before check-in through discharge from the clinic. Other inclusion and exclusion criteria specified in the protocol.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs)

Timeframe: Deaths, SAEs, and AEs: from enrollment through end-of-trial visit Day 21 (±7 days). TEAEs: from first dose of study drug through 72 hours postdose.

Change From Baseline in Supine Bolus Flow Time (BFT)

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose

Change From Baseline in Upright BFT

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose

Change From Baseline in Supine Integrated Relaxation Pressure (IRP)

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose

Change From Baseline in Upright IRP

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose

Change From Baseline in 1 Minute Impedance Bolus Height (IBH)

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose

Trial details

NCT IDNCT02931565

SponsorCyclerion Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-01

Results submitted2021-04-08

View on ClinicalTrials.gov More Achalasia trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Deaths, Serious Adverse Events (SAEs), and Adverse Events Resulting in Study Drug Discontinuation (ADOs)

Timeframe: Deaths, SAEs, and AEs: from enrollment through end-of-trial visit Day 21 (±7 days). TEAEs: from first dose of study drug through 72 hours postdose.

Change From Baseline in Supine Bolus Flow Time (BFT)

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose

Change From Baseline in Upright BFT

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose

Change From Baseline in Supine Integrated Relaxation Pressure (IRP)

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose

Change From Baseline in Upright IRP

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose

Change From Baseline in 1 Minute Impedance Bolus Height (IBH)

Timeframe: Day 1: predose (baseline) and 3 hours (+15 minutes) postdose