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NCT02160288 · ClinicalTrials.gov registry record · Phase 2
Effects of Botox in Obstructed Defecation Syndrome
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT02160288: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.
NCT02160288 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02160288, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve symptoms of constipation in obstructed defecation syndrome (ODS).
Primary Outcome
The primary outcome measure will be the change from baseline in the sum of ODS-S and PAC-QoL at 1 month after the Botox injection. This measures the symptomatic improvement in ODS. ODS (altomare obstructed defecation syndrome score) scores range from 0 (minimum) to 31 (maximum) where 31 is the most severe (worse outcome) and 0 is no symptoms (better outcome). The scale for PAC-QoL (Patient Assessment of Constipation- Quality of life score) is a minimum of 0 and a maximum of 112 where 0 is high
Interventions
- DRUG Normal Saline
- DRUG Botulinum Toxin-A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2016-02 |
| Est. Completion | 2019-06-11 |
| Phase | Phase 2 |
Why NCT02160288 stopped before completion
NCT02160288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT02160288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02160288 about?
NCT02160288 is a clinical study titled "Effects of Botox in Obstructed Defecation Syndrome". The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve symptoms of constipation in obstructed defecation syndrome (ODS).
What is the current status of trial NCT02160288?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2016-02. Estimated completion is 2019-06-11.
What interventions are being tested in trial NCT02160288?
The interventions under investigation include: Normal Saline (DRUG), Botulinum Toxin-A (DRUG).
Who is sponsoring clinical trial NCT02160288?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02160288's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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